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Trials Catalog

  • Recruitment planned
  • Recruitment in progress
  • Participation only by invitation
  • Recruitment completed, FollowUp still running
  • Recruitment completed, FollowUp completed
  • Recruitment temporarily suspended
  • Recruitment permanently discontinued (after start of recruitment)
  • Recruitment withdrawn (before start of recruitment)

Adjuvant Therapy

Title
Die N-PLUS-Studie (A Phase II randomized, open label non-inferiority study of NiraParib maintenance after 3 vs. 6 cycles of platinum-based chemotherapy in completeLy debUlked advanced HRDpositive high-grade ovarian cancer patientS in first line therapy) wird im Rahmen des Europäischen Studiennetzwerks ENGOT (European Network for Gynaecological Oncological Trial Groups) durchgeführt.
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
A Phase II randomized, open label non-inferiority study of NiraParib maintenance after 3 vs. 6 cycles of platinum-based chemotherapy in completeLy debUlked advanced HRDpositive high-grade ovarian cancer patientS in first line therapy

Title
Phase I/II Studie zum Einsatz von Meclofenamate in progredienten MGMT-methylierten Glioblastomen unter Standard Temozolomid Therapie
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. Dietmar Krex
EudraCT-number
2021-000708-39
Description
In the phase I component, the primary objective is to determine the toxicity of meclofenamate (MFA) therapy in addition to standard temozolomide (TMZ) in patients with the first relapse of MGMT promotor methylated glioblastoma. Efficacy, safety, tolerability and impact on quality of life are the secondary objectives. In phase II, the main objective is to determine the efficacy of MFA in addition to TMZ therapy. The primary endpoint in phase I is the incidence of dose-limiting toxicities (DLTs) during the first 8 weeks of MFA treatment. In phase II, the primary endpoint is progression-free survival (PFS) determined according to RANO criteria in cranial MRI.

Title
Bei Captor-BC handelt es sich um eine einarmige Phase IV Studie für Patientinnen mit fortgeschrittenem bzw. metastasierten HER2neg/HRpos Brustkrebs, die in einer Erstlinientherapie den CDK4/6-Inhibitor Ribociclib in Kombination mit einer Antihormontherapie erhalten. In dieser Studie werden molekulare und nicht-molekulare Biomarker untersucht, die sowohl die Effizienz der Behandlung als auch die Bildung von Resistenzen während einer CDK4/6i Therapie vorhersagen. Dazu wird eine umfassende Biomaterialsammlung angelegt, um die Evaluation potentieller prädiktiver Biomarker und weiterer translationaler Forschungsprojekte zu ermöglichen.
Phase
phase IV
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT05452213
Description
A single-arm, open-label, phase IV study investigating the combination of ribociclib and standard endocrine therapy to discover and validate molecular and non-molecular biomarkers predictive of drug response and resistance.

Title
A Multicenter, Open Label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT03486873
EudraCT-number
2017-004417-42
Description
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.

Title
Nicht-interventionelle, prospektive Registerstudie zur Behandlung des Cervixkarzinoms der Stadien FIGO 1b bis 2a durch nervenschonende totale Mesometriale Resektion und therapeutische Lymphonodektomie nach M. Höckel
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
Non-interventional, prospective registry study on the treatment of cervical cancer of FIGO stages 1b to 2a by nerve-sparing total mesometrial resection and therapeutic lymphadenectomy according to M. Höckel

Title
De-Eskalation der adjuvanten Radio(chemo)therapie für HPVpositive Kopf-Hals-Plattenepithelkarzinome. Eine Phase I Studie zur Reduktion der Spättoxizität
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof Dr. med. Mechthild Krause
Registration
NCT03396718

Title
SonoCloud for Bbb opening In gbm Recurrent Disease
Legal foundation
Medizinproduktegesetz
Contact
0351-4584828
Contact E-Mail-Address
andrea.sorokin@ukkd.de
Description
- A randomized, open-label, multicenter, two-arm study of SonoCloud-9 combined with carboplatin versus standard lomustine (CCNU) or temozolomide (TMZ) therapy in patients with operable first recurrence of glioblastoma - Implantable device that is used as a bone flap replacement after resection of the recurrence. Using specific ultrasound frequencies and a substance (microbubbles), the blood-brain barrier can be temporarily opened so that large-molecule chemotherapeutic agents, such as carboplatin, can also penetrate the tissue.

Title
A Phase 2, Randomized, Double-blind, Placebo- and Active-comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection
Phase
phase II
Legal foundation
Arzneimittelgesetz
Examiner
Dr. med. Angelika Borkowetz
Registration
NCT06305767
EudraCT-number
2023-505658-17
Description
The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.

Title
Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation (CIRCULATE)
Phase
n/a
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT04089631
EudraCT-number
2018-003691-12
Description
This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.

Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT06109779
Description
A global study to assess the efficacy and tolerability of rilvegostomig compared toplacebo in combination with investigator's choice of chemotherapy in participants withBTC after surgical resection with curative intent.

Neoadjuvant Therapy

Title
Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer - a Multicenter, Open-label, Umbrella Phase-II Study - COGNITION-GUIDE
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT05332561
EudraCT-number
2020-002606-22
Description
The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials. Eligible patients are identified considering pCR-status and clinical stage estrogen receptor status grade (CPS-EG)-score following surgery after neoadjuvant therapy. Allocation to the therapy- arms is conducted by a molecular tumor board based on in depth molecular characterization of tumors within the COGNITION registry program. Recruitment of adequate patient numbers in well-defined molecular subgroups is achieved in a multicenter approach. The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm. The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.

Title
A Prospective Multicenter Cohort Study to Evaluate Different Surgical Methods of Axillary Staging (Sentinel Lymph Node Biopsy, Targeted Axillary Dissection, Axillary Dissection) in Clinically Node-positive Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. med. Cornelia Meisel
Registration
NCT04373655
Description
The optimal surgical axillary staging technique in patients who convert from the clinically positive to clinically negative lymph node status under neoadjuvant therapy (cN+ â?? ycN0) remains to be clarified. Different strategies (axillary lymph node dissection, sentinel node biopsy, targeted axillary dissection) are currently used in different countries. A prospective analysis comparing these techniques regarding feasibility, safety, morbidity and surgical effort is urgently needed. Due to high complexity and discordant recommendations, a randomized trial comparing different techniques is hardly feasible. Therefore, the EUBREAST study group decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after neoadjuvant therapy.

Title
PROton versus photon Therapy for Esophageal Cancer. A Trimodality strategy (PROTECT). A multicenter international randomized phase III study of neoadjuvant proton versus photon chemoradiotherapy in locally advanced esophageal cancer.
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof. Dr. med. Dr. Esther Troost
Registration
050555648
Description
The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT).

Title
CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT05774951
Description
This is a Phase III open-label study to assess if camizestrant improves outcomes comparedto standard endocrine therapy in patients with ER+/HER2 - early breast cancer withintermediate or high risk for disease recurrence who completed definitive locoregionaltherapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) forat least 2 years and up to 5 years. The planned duration of treatment in either arm ofthe study is 60 months.

Title
Phase 3, Open-Label, Randomized Study of Neoadjuvant Datopotamab Deruxtecan with Durvalumab +/- Chemotherapy followed by Adjuvant Durvalumab, Versus Neoadjuvant Pembrolizumab + Chemotherapy and Adjuvant Pembrolizumab, in Patients with Stage II-III Triple Negative Breast Cancer
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT06112379
Description
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

First-Line-Therapy (Metastatic Disease/Hematology)

Title
Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T cells Carrying Reverse Chimeric Antigen Receptors (Allo-RevCAR01-T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123.
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05949125
EudraCT-number
2022-501797-19
Description
The Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug. The cellular component Allo-RevCAR01-T consists of an allogeneic human T-cell genetically multi-edited and expressing a reversed, universal chimeric antigen receptor (RevCAR) presenting an extracellular peptide epitope (RevCAR epitope). R TM123 functions as a bridging module between Allo RevCAR01-T and a CD123-expressing target cancer cell by selectively binding the RevCAR epitope and CD123.

Title
Decision for or against Anti-PD-1 Treatment In Adjuvant Setting of Patients across Europe with Resected Stage IIB/IIC Melanoma
Legal foundation
Berufsordnung
Contact
+49 351-45819782
Contact E-Mail-Address
oncostudien.dermatologie@ukdd.de
Examiner
Prof. Dr. med. Friedegund Meier
Description
This study is to describe the treatment rates for adjuvant anti-PD1 antibody therapy in patients with resected stage IIB/IIC cutaneous melanoma and to describe determinants for recommendations of treating physicians and/or interdisciplinary tumor boards about adjuvant treatment in Stage IIB/IIC resected melanoma. The study is also to describe motivations of declining recommended/offered adjuvant treatment among patients with resected Stage IIB/IIC melanoma.

Title
IDE196 (Darovasertib) in combination with Crizitinib versus Investigator´s Choice of treatment as first-line therapy in HLA-A2 negative metastatic uveal melanoma
Phase
phase II/III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-45819782
Contact E-Mail-Address
oncostudien.dermatologie@ukdd.de
Examiner
Prof. Dr. med. Friedegund Meier
EudraCT-number
2023-506686-66
Description
IDE196 (Darovasertib) in combination with Crizitinib versus Investigator´s Choice of treatment as first-line therapy in HLA-A2 negative metastatic uveal melanoma

Title
Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT06151574
Description
This study is open to adults 18 years and older with advanced or metastatic non-smallcell lung cancer. People can join the study if they have tumours with HER2 mutations andhave not yet received any systemic therapy including chemotherapy for advanced ormetastatic lung cancer. The purpose of this study is to find out whether a medicinecalled zongertinib (BI 1810631) can slow down the worsening of advanced non-small celllung cancer better than the standard treatment available. Zongertinib may slow cancercell growth by inhibiting HER2. This would prolong cancer re-occurrence and increasesurvival. Current standard treatment is pembrolizumab plus platinum-pemetrexedchemotherapy.Participants are put into 2 groups by chance. One group receives zongertinib at regulartimes throughout the study and the other group receives infusions of pembrolizumab,pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexedchemotherapy) into a vein.Participants may be in the study up to a

Title
A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT06662786
Description
The purpose of this study is to compare how long the participants are disease-free(progression-free survival) when treated with amivantamab and chemotherapy with5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin(mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, andirinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adultparticipants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RASviral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF)wild type (WT) unresectable or metastatic left-sided colorectal cancer.

Title
Pelvic lymphadenectomy in vulvar cancer
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
This retrospective, multicenter study is designed to collect therapeutic data from all patients diagnosed with primary inguino- femorally node- positive squamous cell vulvar cancer (VSCC) and treated with surgical staging of the groin/s in 2017-2019 at the gynaecological cancer centers participating in the AGO CaRE-1 Study.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2024-514473-21-00
Description
To demonstrate the superiority of de-escalated induction therapy followed by autologous stem cell transplantation compared to the standard MATRix protocol in terms of event-free survival (EFS).

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2023-507402-13-00
Description
A randomized phase III trial assessing iberdomide versus iberdomide plus isatuximab maintenance therapy post autologous hematopoietic stem-cell transplantation in patients with newly diagnosed multiple myeloma

Title
A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT06211036
Description
The primary objective of this study is to compare the efficacy of tarlatamab plusdurvalumab with durvalumab alone on prolonging overall survival (OS).

Title
WoO: Window of Opportunity (â??Gelegenheitsfensterâ??) Studie zu Olaparib und Durvalumab in histologisch nachgewiesenem EOC
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
EudraCT-number
2020-005101-12
Description
Window-of-opportunity proof-of-concept, non-randomized, openlabel phase II trial of Olaparib given alone (cohort A) or in combination with Durvalumab (cohort B) prior to primary debulking surgery in histologically proven high-grade epithelial ovarian cancer (EOC)

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2022-000760-21
Description
Ph+ ALL, ponatinib compared to imatinib in combination with low-intensity chemotherapy, to compare end of therapy with indication for SCT with TKI in combination with blinatumomab and chemotherapy in optimal response and to assess blinatumomab before SCT in suboptimal response

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2021-000330-33
Description
Individualized Immunotherapy in Early-Stage Unfavorable Hodgkin Lymphoma

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2024-512320-11-00
Description
The primary objective of this study is to investigate if intensified chemotherapy followed by consolidating high-dose chemotherapy and autologous stem-cell transplantation (HDTASCT) is superior to conventional chemotherapy with R-MP followed by maintenance in elderly patients with newly diagnosed PCNSL regarding 1-year progression free survival (PFS). Secondary objectives are the investigation of quality of life, remission after treatment, event free survival, overall survival (OS) and treatment related morbidities (neurotoxicity and adverse events).

Title
Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naive ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT06140836
Description
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naive ROS1-positive non-small cell lung cancer (NSCLC).

Title
Additional Chemotherapy for EGFRm Patients With the Continued Presence of Plasma ctDNA EGFRm at Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05281406
Description
PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.

Title
Eine randomisierte, offene Phase-II-Studie zum Vergleich einer neoadjuvanten endokrinen Therapie in Kombination mit Trastuzumab, Pertuzumab +/- dem PI3K-Inhibitor Inavolisib bei Patienten mit HER2-positivem, HR-positivem, PIK3CA-mutiertem primären Brustkrebs - GeparPiPPa
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. Theresa Link
EudraCT-number
2022-501152-28
Description
This is a multicenter, prospective, randomized, open-label, parallel-group, phase II study to evaluate the potential incremental efficacy and safety of inavolisib in the neoadjuvant treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer. 170 patients with confirmed eligibility criteria and PIK3CA mutant breast cancer will be randomized in a 1:1 ratio to receive: Neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous (PH-FDC SC) formulation q3w for 6 cycles (18 weeks) • with inavolisib (6 cycles) or • without inavolisib. Endocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue. In both study arms, treatment will be given until surgery/core-biopsy, disease progression, unacceptable toxicity, or withdrawal of consent of the patient. All patients will undergo surgery or biopsy after completing study therapy to assess pCR rate. In case of ycT0 and no tumor residuals in the biopsy, it is recommended to undergo surgery; in case of tumor residuals in the biopsy further neoadjuvant treatment may be given (the patient will be considered no pCR for the study regardless of the response to the further neoadjuvant treatment). Pseudonymized histology and surgery reports will be collected. Further neoadjuvant or adjuvant treatment including chemotherapy, radiotherapy, endocrine therapy and HER2-therapy will be administered at the discretion of the investigator and according to standard of care. Information on those additional adjuvant treatments will be captured within a registry.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2022-501537-23-00
Description
An open-label, single-arm, pilot study of Venetoclax in combination with 5-day courses of Azacitidine in treatment-nai¨ve subjects with acute myelogenous leukemia who are =18 years of age and not eligible for standard induction therapy - VENAZA-5S PILOT TRIAL

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2022-001672-34
Description
This is a multicenter, randomized, double-blinded Phase 3 study to assess the efficacy and safety of two different doses of ianalumab (3 and 9 mg/kg) compared to placebo in adult participants with primary ITP.

Title
The ABC-HCC Trial: A Phase IIIb, Randomized, Multicenter, Open-label Trial of Atezolizumab Plus Bevacizumab Versus Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Dr. med. Anke Kröcher
Registration
NCT04803994
Description
The ABC-HCC trial is a Phase IIIb, randomised, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab versus TACE in patients with intermediate-stage HCC. Approximately 434 patients in two arms of treatment will be enrolled.

Title
Atezolizumab/Carboplatin/Nab-Paclitaxel vs. Pembrolizumab/Platinum/Pemetrexed in Metastatic TTF-1 Negative Lung Adenocarcinoma
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Dr. med. Felix Saalfeld
Registration
NCT05689671
Description
This is an open-label randomized, controlled, multicenter, phase II trial with two arms. Patients with metastatic TTF-1 negative, treatment-naive lung adenocarcinoma without actionable genomic alterations are randomized in a 1:1 manner to investigate the efficiency of atezolizumab, carboplatin and nab-paclitaxel (Arm A) versus pembrolizumab, cis-/carboplatin and pemetrexed (Arm B) as first-line treatment.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2019-003863-23
Description
Midostaurin + Gemtuzumab OzogAmIcin Combination in First-line Standard therapy for core-binding factor acute myeloid leukemia oder for FLT3-mutated acute myeloid leukemia.

Title
An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer
Phase
phase III
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT06282575
Description
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plusCisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed deathprotein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab orPembrolizumab, where approved under local regulations) as first line of treatment forparticipants with human epidermal growth factor receptor 2 (HER2)-positive biliary tractcancer.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2022-502660-20-00
Description
AN OPEN-LABEL, RANDOMIZED, PHASE III STUDY TO COMPARE THE EFFICACY AND SAFETY OF ODRONEXTAMAB (REGN1979), A BISPECIFIC ANTI-CD20 X ANTI-CD3 ANTIBODY, VERSUS INVESTIGATOR'S CHOICE IN PREVIOUSLY UNTREATED PARTICIPANTS WITH FOLLICULAR LYMPHOMA

Title
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1).
Phase
phase I
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT03093116
EudraCT-number
2016-003616-13
Description
This is an investigational study of a drug named Reprotrectinib that will be given to patients with advanced solid tumors with ALK, ROS1, or NTRK1-3 rearrangements. Repotrectinib will provide opportunities in clinic to stop the abnormal cell signaling of ALK/ROS1/TRKs in solid malignancies, and overcome your body’s natural resistance to treatment of advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements.

Title
An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT06421935
EudraCT-number
2024-513492-41
Description
An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2021-005433-16
Description
Phase-I-Studie zur Beurteilung der kardialen Sicherheit einer Konditionierungstherapie auf Treosulfan-Basis bei Patienten mit AML oder MDS, die sich einer allogenen hämatopoetischen Stammzelltransplantation unterziehen

Title
A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC) (eVOLVE-Lung02)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Examiner
Dr. med. Felix Saalfeld
Registration
NCT05984277
EudraCT-number
2023-000056-38
Description
A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC)

Title
Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma
Phase
phase II/III
Legal foundation
Arzneimittelgesetz
Examiner
Dr. med. Stephan Richter
Registration
NCT06088290
Description
The primary objective of this phase IIb/III study is to evaluate whether the combinationof lurbinectedin plus doxorubicin given as first line treatment for metastaticleiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent ReviewCommittee (IRC) when compared to doxorubicin administered as a single agent.

Title
Niraparib vs Niraparib in Combination With Bevacizumab in Patients With Carboplatinum-taxane Based Chemotherapy in Advanced Ovarian Cancer (A Multicentre Randomised Phase III Trial)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT05009082
EudraCT-number
2021-001271-16
Description
This is an international, multicenter, randomized, open, Phase III trial to evaluate theefficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab andniraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newlydiagnosed advanced ovarian cancer.

Title
Fedratinib in Combination with CC-486, a Hypomethylating Agent, in Patients with Accelerated Phase Myelofibrosis.
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Dr. Katja Sockel
EudraCT-number
2021-003650-23
Description
Fedratinib in Combination with CC-486, a Hypomethylating Agent, in Patients with Accelerated Phase Myelofibrosis.

Title
Eine randomisierte kontrollierte Phase-III-Studie zu IMC-F106C plus Nivolumab im Vergleich zu Nivolumab-Schemen bei HLA A*02:01-positiven Teilnehmern mit zuvor unbehandeltem fortgeschrittenem Melanom (PRISM-MEL-301)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-45819782
Contact E-Mail-Address
oncostudien.dermatologie@ukdd.de
Examiner
Prof. Dr. med. Friedegund Meier
EudraCT-number
2023-505306-42
Description
A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Title
An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05048797
EudraCT-number
2021-000634-33
Description
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

Title
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. Theresa Link
Registration
NCT06465368
EudraCT-number
2024-512848-30
Description
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING

Title
Influence of Radiation on Immune respoNse to checkpoint blocker treatment in patients with metastasized melanomA
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof. Dr. med. Dr. Esther Troost
Description
The aim of the study is to evaluate the influence of timing of radiotherapy, i.e., to detect potential beneficial immune modulatory effects of radiotherapy affecting disease outcome in patients with metastatic melanoma. The primary endpoint will be the influence of early irradiation on progression free survival (PFS), and in case a positive effect is found, in a second step (co-primary endpoint), the overall response rate (ORR) to radiotherapy as a function of timing.

Title
MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer: a Randomized Double-blinded Placebo-controlled Multi-centre Phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO), Including LOGOS (Low Grade Ovarian Cancer Sub-study).
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT04111978
Description
The purpose of this study is to evaluate the efficacy of addition of letrozole to the standard maintenance therapy in subjects following a primary diagnosis of Estrogen-receptor (ER) positive high and low grade epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) and subsequent primary treatment surgeryand chemotherapy. Half of the participants will receive to the standard maintenance treatment, letrozole, whilst the other half receives placebo.The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).

Title
A Phase 1/2 Open-Label, Umbrella Platform Design Study of MK-2870 With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT06469944
Description
This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluatethe safety and tolerability of sacituzumab tirumotecan with pembrolizumab andfluoropyrimidine chemotherapy for the first-line (1L) treatment of participants withlocally advanced unresectable or metastatic human epidermal growth factor receptor 2(HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.This substudy will have two phases: a safety lead-in phase and an efficacy phase. Thesafety lead-in phase will be used to evaluate the safety and tolerability, and toestablish a recommended Phase 2 dose (RP2D) for sacituzumab tirumotecan in combinationwith chemotherapy and immunotherapy. There is no formal hypothesis in this study.

Title
An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT05253651
Description
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: - mFOLFOX6 alone, - mFOLFOX6 with bevacizumab, or - mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

Title
Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. Theresa Link
Registration
NCT05512364
EudraCT-number
2022-501453-36
Description
The study investigates whether treatment with elacestrant (an oral selective estrogen receptor degrader: SERD) leads to better treatment outcomes compared to standard antihormonal therapy. During the ctDNA screening phase, patient blood samples are regularly tested for circulating tumor DNA (ctDNA, so-called liquid biopsy). If ctDNA is detected, patients without evidence of distant metastases receive antihormonal therapy. This is a randomized study. Patients receive either elacestrant (oral) or standard antihormonal therapy

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2021-003248-26
Description
Venetoclax plus azacitidine versus standard intensive chemotherapy for patients with newly diagnosed acute myeloid leukemia (AML) and NPM1 mutations eligible for intensive treatment

Title
A phase 3 trial of Fianlimab 8REgn3767, Anti-Lag-3) + Cemiplimab versus Pemprolizumab in patients with previously untreated unresectable locally advanced or metastatic melanoma
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-45819782
Contact E-Mail-Address
oncostudien.dermatologie@ukdd.de
Examiner
Prof. Dr. med. Friedegund Meier
EudraCT-number
2021-004453-23
Description
A phase 3 trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab versus Pembrolizumab in patients with repviously untreated unresectable locally advanced or metastatic melanoma.

Title
A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT04929223
Description
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2022-001186-12
Description
A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab- and Talquetamab-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2020-004360-26
Description
A Prospective, Open-Label, Multicenter, Randomized, Phase 3 Trial of Acalabrutinib, Obinutuzumab and Venetoclax (GAVe) Compared to Obinutuzumab and Venetoclax (GVe) in Previously Untreated Patients with High Risk (17p-deletion, TP53- mutation or complex karyotype) Chronic Lymphocytic Leukemia (CLL)

Title
A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3).
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT04429087
EudraCT-number
2019-000729-31
Description
To determine the maximum tolerated dose(s) (MTD) or the Recommended Dose for Expansion (RDE) and dosing regimen for further development of BI 764532. The MTDs will be defined based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period in studied regimens. The Recommended Dose for Expansion (RDE) will be guided by overall safety, efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) assessments. Additional objectives are to document the safety and tolerability of BI 764532, to characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals. Phase Ib will further explore BI 764532 in selected patients populations based on data from phase Ia. The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2023-505394-32
Description
Eine randomisierte, doppelblinde, multizentrische Phase-III-Studie zur Beurteilung der Wirksamkeit und Sicherheit von Belumosudil in Kombination mit Kortikosteroiden im Vergleich zu Placebo in Kombination mit Kortikosteroiden bei Teilnehmern im Alter von mindestens 12 Jahren mit neu diagnostizierter chronischer Graft-versus-Host-Erkrankung (cGVHD)

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2022-000996-38
Description
A randomized phase III non-inferiority trial assessing lenalidomide, bortezomib and dexamethasone induction therapy with either intravenous or subcutaneous isatuximab in transplant-eligible patients with newly diagnosed multiple myeloma

Title
A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Dr. med. Ulrike Ubbelohde
Registration
NCT06525220
Description
This is Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent ormetastatic PD-L1+ head and neck squamous cell carcinoma.

Title
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. Christian Thomas
Registration
NCT06120491
Description
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) +physician's choice NHA relative to placebo + physician's choice NHA by assessment ofradiographic progression-free survival (rPFS) in participants with mCSPC.

Follow-Up Treatment (Metastatic Disease)

Title
PHASE III STUDY COMPARING TRABECTEDIN (T) VERSUS T PLUS tTF-NGR TO ENTRAP T INSIDE THE TUMOR IN PATIENTS WITH METASTATIC AND/OR REFRACTORY SOFT TISSUE SARCOMA (STS; 2nd LINE)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Dr. med. Stephan Richter
Description
PHASE III STUDY COMPARING TRABECTEDIN (T) VERSUS T PLUS tTF-NGR TO ENTRAP T INSIDE THE TUMOR IN PATIENTS WITH METASTATIC AND/OR REFRACTORY SOFT TISSUE SARCOMA (STS)

Title
A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT06107413
Description
Cancer is a condition where cells in a specific part of body grow and reproduceuncontrollably. The purpose of this study is to assess adverse events and change indisease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid,and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer.ABBV-400 is an investigational drug being developed for the treatment of unresectablemetastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab is an drugapproved for the treatment of unresectable metastatic colorectal cancer. Study doctorsput the participants in groups called treatment arms. Each treatment arm receives adifferent dose of ABBV-400 in combination with fluorouracil, folinic acid, andbevacizumab (FFB) in escalating doses on two different schedules (safety lead in),followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil,folinic acid, irinotecan, and bevacizumab (standard of care [SOC]) [dose optimizat

Title
A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT06016738
Description
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) tothe standard-of-care options of fulvestrant or an aromatase inhibitor in women and menwith breast cancer whose disease has advanced on one endocrine therapy in combinationwith a CDK4/6 inhibitor.

Title
A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of MK-2870 Plus Paclitaxel as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT06445972
Description
This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluatethe safety and efficacy of MK-2870 plus paclitaxel versus Ramucirumab plus paclitaxel,for the treatment of participants with advanced or metastatic gastric adenocarcinoma,gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who havefailed 1 prior line of therapy. This is an estimation study, and no formal hypothesistesting will be performed.

Title
A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT06072781
Description
A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Title
A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT05563220
EudraCT-number
2022-002609-10
Description
A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE)

Title
A phase III, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with p53 wild-type, advanced, or recurrent endometrial carcinoma: rationale, methods, and trial design
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT0561193
Description
A phase III, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with p53 wild-type, advanced, or recurrent endometrial carcinoma: rationale, methods, and trial design

Title
A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT06162221
Description
The purpose of this platform study is to evaluate the safety, tolerability,pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitorscombined with Standard(s) of Care (SOC) or with each other.The first two subprotocols include the following:Subprotocol A: RMC-6291 + SOC Subprotocol B: RMC-6236 + SOC

Title
A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Tislelizumab in Patients With Select Advanced Cancers
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05544929
EudraCT-number
2022-502381-25
Description
This is a phase I, open-label, multi-center study of KFA115 as a single agent and in combination with tislelizumab. The study consists of a dose escalation part, followed by dose expansion part(s) for single-agent KFA115 and KFA115 in combination with tislelizumab. The escalation parts will characterize safety and tolerability. After the determination of the maximum tolerated dose (MTD) / recommended dose (RD), the dose expansion parts will assess the preliminary anti-tumor activity in defined patient populations and further assess the safety and tolerability at MTD/RD.

Title
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigators Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)
Phase
phase II/III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-45819782
Contact E-Mail-Address
oncostudien.dermatologie@ukdd.de
Examiner
Prof. Dr. med. Friedegund Meier
Registration
NCT05549297
Description
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator’s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)

Title
A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. Christian Thomas
Registration
NCT06136650
Description
The purpose of this study is to assess the efficacy and safety of MK-5684 plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that MK-5684 is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Title
A PHASE 1 SINGLE-ARM, OPEN-LABEL STUDY OF CA-4948 IN COMBINATION WITH AZACITIDINE AND VENETOCLAX IN ACUTE MYELOID LEUKEMIA PATIENTS IN COMPLETE RESPONSE WITH MEASURABLE RESIDUAL DISEASE.
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
EudraCT-number
2023-505828-58
Description
A Phase 1 Single-Arm, Open-Label Study of CA-4948 in Combination with Azacitidine and Venetoclax in Acute Myeloid Leukemia Patients in Complete Response with Measurable Residual Disease.

Title
A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects with Methylthioadenosine Phosphorylase (MTAP)-deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC).
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT06593522
EudraCT-number
2024-514459-14
Description
The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR)

Title
Comprehensive Assessment of Clinical Features and Biomarkers to Identify Patients With Advanced or Metastatic Breast Cancer for Marker Driven Trials in Humans (CATCH)
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT05652569
Description
CATCH is an indication-specific diagnostic platform, which drives the implementation ofintegrative, genomic profiling for metastatic breast cancer into the clinics. The mainobjective of this approach is to identify biomarkers and drug targets to guide targetedtherapeutic interventions.Eligible are all metastatic breast cancer patients (independent of gender), irrespectiveof molecular subtype.At initial diagnosis of distant metastasis or progress at disease progression, biopsysamples from a prognostic-relevant metastasis are retrieved during standard-of-careprocedures for central analyses, together with blood samples. In parallel to allstandard-diagnostic measures, genomic and transcriptomic profiling is conducted to inferthe underlying biology of the disease and identify patients who might profit frombiomarker-guided interventions in clinical trials.Samples not required for standard-of-care clinical procedures or genomic profiling aresystematically collected in a dedicated bio-reposit

Title
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT05319730
Description
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study toevaluate the safety and efficacy of investigational agents with or without pembrolizumaband/or chemotherapy, for the treatment of participants with second line (2L) esophagealsquamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 basedtreatment.

Title
A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT04614103
EudraCT-number
2020-003629-45
Description
This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic NSCLC.

Title
Eine randomisierte, multizentrische, offene Phase-III-Studie zu DB-1303 im Vergleich zu einer Chemotherapie nach Wahl des Prüfarztes bei Patienten mit humanem epidermalem Wachstumsfaktor-Rezeptor 2(HER2)-niedrigem, Hormonrezeptor-positivem (HR+) metastasiertem Brustkrebs, deren Erkrankung unter einer endokrinen Therapie (ET) fortgeschritten ist (DYNASTY-Breast02)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. Theresa Link
Registration
NCT06018337
Description
A randomized, multicenter, open-label, phase III study of DB-1303 versus investigator-choice chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-low, hormone receptor-positive (HR+) metastatic breast cancer whose disease has progressed on endocrine therapy.

Title
DAREON-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With Topotecan for the Treatment of Patients With Small Cell Lung Cancer
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05990738
Description
This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive topotecan treatment. The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions into a vein. As an alternative, topotecan may also be taken orally (tablets). Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.

Title
A Phase Ia/Ib First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA401, a Bispecific T Cell Engaging Receptor Molecule (TCER®), in Patients With Recurrent and/or Refractory Solid Tumors.
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05359445
EudraCT-number
2021-004326-30
Description
Primary objective: - To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 Secondary objectives: - To characterize the safety and tolerability of IMA401 - To evaluate initial anti-tumor activity of IMA401 - To describe the pharmacokinetics of IMA401

Title
A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) with EGFR Mutations or Other Genomic Alterations
Phase
phase III
Legal foundation
Arzneimittelgesetz
Examiner
Dr. med. Felix Saalfeld
Registration
NCT06074588
Description
The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Title
A Phase I, non-randomized, open-label, multi-center dose escalation trial of BI 764532 combined with ezabenlimab in patients with Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3.
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT5879978
EudraCT-number
2022-502728-30
Description
This study is open to adults with small cell lung cancer and other neuroendocrine tumours that are positive for the tumour marker Delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with another medicine called ezabenlimab. BI 764532 and ezabenlimab are antibodies that may help the immune system fight cancer. Participants get BI 764532 and ezabenlimab as infusions into a vein. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about every week. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.

Title
A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician's Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. Gunnar Folprecht
Registration
NCT06356311
Description
This study will compare how safe and effective sacituzumab tirumotecan is versus thetreatment of physician's choice (TPC) in participants with advanced/metastaticgastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumabtirumotecan is superior to TPC with respect to Overall Survival (OS).

Title
Prospektive, randomisierte, monozentrische Studie zum Einfluss einer intensiven Ernährungsberatung auf die Lebensqualität bei Patienten mit metastasiertem Brustkrebs unter CDK4/6- oder mTOR-Inhibition
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
Prospective, randomized, single-center study on the impact of intensive nutritional counseling on quality of life in patients with metastatic breast cancer under CDK4/6 or mTOR inhibition

Follow-Up Treatment

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
A Phase 1b/2 Study of BGB-11417 in Monotherapy and in Various Combinations with Dexamethasone plus Carfilzomib, Dexamethasone plus Daratumumab, and Dexamethasone plus Pomalidomide in Multiple Myeloma

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2020-002393-27
Description
A Phase 2 Multicenter Study of TL-895 in Subjects with A Phase 2 Multicenter Study of TL-895 in Subjects with A Phase-II multicenter study of TL-895 in subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2020-002324-36
Description
A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies This is a multicenter, non-randomized open-label, Phase 2 dose escalation and confirmation followed by a multi-cohort single-group study. This study is designed to first establish the RP2D and then as a proof-of-concept to assess the efficacy and safety of MK-1026 monotherapy across cohorts of participants with various hematological malignancies who have relapsed or are refractory to prior therapies. BTK inhibitors are approved for the treatment of several lymphoproliferative malignancies; however, resistance is known to develop. These hematologic malignancies were selected because each represents a significant unmet medical need and prior BTK inhibitors have shown efficacy in these malignancies.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2022-002850-13
Description
Assess the Safety and Efficacy of Bomedemstat (IMG-7289) versus Best Available Therapy (BAT) in Patients with Essential Thrombocythemia who are Resistant to or Intolerant of Hydroxyurea

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2019-001462-15
Description
MSCs (MC0518) vs. BAT in subjects with steroid-refractory aGvHD after allogeneic HSCT

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2021-001384-25
Description
Venetoclax in addition to Venetoclax in addition to Blinatumomab immunotherapy in adult patients with relapsed/refractory B cell precursor acute lymphoblastic leukemia (BCP-ALL)

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients with Relapsed and/or Refractory Multiple Myeloma

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2020-003288-24
Description
This is an open-label, randomized (2:1), multicenter, Phase 3 study of imetelstat compared with BAT in approximately 320 participants with intermediate-2 or high-risk MF (primary MF [PMF], post-ET-MF [PET-MF], or post-PV-MF [PPV-MF]) who are refractory to JAK-inhibitor treatment.

Title
Internationale Studie für die Behandlung von Kindern mit Rückfall einer akuten lymphoblastischen Leukämie (ALL) im Hochrisiko
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
EudraCT-number
2012-000810-12
Description
Primary objective: To improve rates of complete remission (CR) in HR ALL relapse patients. Secondary objectives: Improve rates of event-free survival (EFS) and overall survival (OS) Improvement in MRD reduction after induction with versus without bortezomib Evaluation of the toxicity of induction with versus without bortezomib Evaluation of the efficacy of the consolidation elements with regard to reducing the MRD burden until to allo-HSCT

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2022-500861-29-00
Description
A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480(BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
EudraCT-number
2018-000853-29
Description
Treatment of chemo-rerfractory viral infections after allogeneic stem cell transplantation with multispecific T cells against CMV, EBV and AdV: A phase III, prospective, multicentre clinical trial

Surgical Studies

Title
Effekt einer zusätzlichen Braun-Fußpunkt-Anastomose bei Patienten nach Pankreaskopfresektion
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Marius Distler
Description
The pylorus-preserving partial pancreatoduodenectomy according to Transverso-Longmire is one of the most complex and demanding operations for surgeons as well as for patients. Depending on the expertise of the center as well as the surgeon, the mortality rate increases from less than 5% in centers specializing in pancreatic surgery to more than 10%. Pancreatic fistulas represent a major risk factor for postoperative mortality. Depending on the severity of the clinically relevant pancreatic fistula, the mortality rate increases to 40%. Several reconstruction techniques have been developed to minimize the risk of postoperative complications. The most commonly used reconstruction technique is the Child reconstruction. Here, the pancreaticojejunostomy, the hepaticojejunostomy, and the duodenojejunostomy are attached to a single jejunal loop. In this randomized-controlled study, the benefit of an additional anastomosis between the afferent and efferent loop of the duodenojejunostomy - also called Braun's anastomosis - is to be explored. This is intended to facilitate the outflow of bile and pancreatic fluids from the afferent loop while reducing reflux from the efferent loop, thus relieving the pressure on the pancreaticojejunostomy. This should reduce not only the rate of pancreatic fistulae but also the rate of postoperative complications per se.

Title
Anatomische Resektion von Lebermetastasen bei Patienten mit RAS-mutiertem kolorektalem Karzinom
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Jürgen Weitz
Registration
NCT04678583
Description
The ARMANI study aims to test the hypothesis that anatomic resection (AR) compared to non-anatomic resection (NAR) of liver metastases prolongs intrahepatic disease-free survival of patients with RAS mutated CRLM. The study will be conducted at 20 centers in Germany with high caseloads for hepatobiliary surgery. A total of 240 patients will be enrolled and randomized to AR versus NAR in a 1:1 ratio.

Title
Minimal invasive versus offene Gastrektomie. Eine multizentrische randomisierte kontrollierte Studie.
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Daniel Stange
Description
People diagnosed with gastric tumor require surgery to remove the stomach. The previous standard is open gastrectomy. In recent years, minimally invasive surgery ("small incision surgery" or "keyhole surgery") has developed rapidly and is already replacing open surgery as the standard therapy for many general surgical operations. In gastric cancer, too, some studies show that the minimally invasive approach potentially reduces complication rates with equivalent chances of cure. The goal of this study is to show a reduction in severe complications and postoperative pain, better mobilization, faster rehabilitation, and shorter hospital stay after minimally invasive gastrectomy compared with open gastrectomy. For this reason, the Comprehensive Complication Index (CCI), based on the Clavien-Dindo classification, was chosen as the primary endpoint because this well-established index encompasses all possible complications and thus also reflects the patient's assessment better than other indices. Through this study, surgeons will be better able to educate patients about the benefits and risks of surgery using high-quality data, as well as improve the surgical management of gastric cancer through low complication and faster rehabilitation of patients. This would be associated with a shorter hospital stay, which in turn would reduce the burden on the healthcare system.

Title
Prophylaktische HIPEC kombiniert mit FLOT-Chemotherapie im Vergleich zu alleiniger FLOT-Chemotherapie vor und nach Operation bei Patienten mit diffusem Typ Magenkrebs oder Tumoren des Übergangs zwischen Magen und Speiseröhre - Die PREVENT Studie - eine randomisierte, offene, multizentrische Phase-III Studie der AIO / CAOGI / ACO
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Daniel Stange
EudraCT-number
2017-003832-35
Description
This randomized, open-label, multicenter phase III trial is evaluating the efficacy and safety and tolerability of perioperative chemotherapy in combination with intraoperative `Hyperthermic IntraPEritoneal Chemotherapy' (HIPEC) for resectable adenocarcinoma of the stomach or gastroesophageal junction

Title
Decompressing stoma and two-stage elective resection vs. emergency resection in patients with left-sided obstructive colon cancer
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Dr. med. Mathieu Pecqueux
Description
Colorectal cancer is the third leading cause of cancer death in both men and women in the United States and the second leading cause of cancer death in men and the third leading cause of cancer death in women in Europe. Worldwide, colorectal cancer is responsible for 19.0 million (18.5-19.5) disability-adjusted life years (DALYs). The risk of developing colorectal cancer increases into old age. More than half of patients develop the disease after the age of 70, and only about 10% of cancers occur before the age of 55. About 20 % of patients initially present with acute colonic obstruction, which is one of the most common causes of surgical emergencies. International guidelines do not agree on the optimal treatment for left-sided obstructing colon cancer. In general, two therapeutic approaches are common: Emergency single-stage resection of the obstructing tumour, with or without creation of a stoma, or two-stage resection with a decompressive stoma creation in the first stage and elective oncological resection after convalescence in the second stage, usually after about 20-30 days. Both procedures have advantages and disadvantages. Data from recent retrospective studies suggest that the two-stage bridge-to-surgery (BTS) approach may reduce 90-day mortality and long-term survival in patients with left-sided obstructive colon cancer. In addition to reducing mortality, BTS may also reduce the number of patients requiring a permanent stoma and facilitate the performance of minimally invasive colon resection, leading to a higher quality of life.

Title
Distal Pancreatectomy - A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection (DISPACT-2 Trial)
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Marius Distler
Description
Open distal pancreatectomy is the gold standard in the surgical treatment of pancreatic body and tail disease. The open abdominal approach could lead to increased postoperative morbidity due to the greater surgical trauma compared with minimally invasive distal pancreatectomy, which affects both the patient and the healthcare system. A systematic review demonstrated reduced postoperative morbidity after laparoscopic versus open abdominal approaches across the field of abdominal surgery. The minimally invasive approach, with its less invasiveness, promises to reduce postoperative pain and subsequently improve patient mobilization and reduce respiratory complications, leading to faster recovery and shorter hospital stays. Therefore, in the presence of the same postoperative morbidity, the minimally invasive approach should be offered to patients as the first choice.

Title
Radikale antegrade modulare Pankreatosplenektomie (RAMPS) im Vergleich zur konventionellen distalen Pankreatosplenektomie bei Bauchspeicheldrüsenkrebs
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Marius Distler
Description
To investigate whether the RAMPS technique increases achievement of R0 resection margins in comparison to standard distal pancreatosplenectomy.

Title
Pancreatic Head Resection or Total Pancreatectomy With Islet Autotransplantation (IAtx) in Patients With Periampullary Cancer and High Risk Profile for the Development of Postoperative Pancreatic Fistula (POPF)
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Marius Distler
Registration
NCT05843877
EudraCT-number
2023-507773-17
Description
The primary objective of this clinical trial is to evaluate whether primary totalpancreatectomy with simultaneous islet autotransplantation compared with pancreatic headresection (alone) can reduce perioperative morbidity and time to initiation of adjuvanttherapy in patients with a high-risk constellation for pancreatic fistulas.

Radiotherapy Studies

Title
Protonenbehandlung zur primären Radiochemotherapie bei fortgeschrittenen Nicht-kleinzelligen Bronchialkarzinomen zur Verminderung der Normalgewebstoxizität
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof. Dr. med. Dr. Esther Troost
Registration
NCT02731001

Title
Hirnleistungsfähigkeit nach Protonentherapie bei Kindern und Jugendlichen. Eine longitudinale Bewertung der kurz- und mittelfristigen Effekte der Protonen-Strahlentherapie im Vergleich zu nicht bestrahlten Kindern auf die kognitiven Prozesse bei Kindern und Jugendlichen mit Hirntumoren
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof Dr. med. Mechthild Krause
Registration
NCT04066465
Description
In the present study, the short and medium-term consequences of proton therapy on cognitive processes are to be highlighted. In a second step, these findings will be compared with a group of children and adolescents who did not receive radiotherapy as part of their curative brain tumor therapy (surgical therapy alone) and with a healthy control group. In this way, the extent to which these treatment options differ in terms of their short and medium-term consequences will be determined. Brain research approaches are used that make it possible to visualize even small changes in mental performance. This means that treatment effects can be easily recorded and thus improve the treatment of children and adolescents with brain tumors in the future.

Title
Protonentherapie von Tumoren der Schädelbasis: Prospektive Erfassung von Effizienz und Nebenwirkungen bei klinischen Standarddosen
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof Dr. med. Mechthild Krause

Title
Protonentherapie von Prostatakarzinomen: Prospektive Erfassung von Effizienz und Nebenwirkungen bei klinischen Standarddosen
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Tobias Hölscher

Title
Prostatalogenbestrahlung mit Alternativen RadioOnkologischen AnSätzen
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Tobias Hölscher

Title
Effektivität und Toxizität einer perkutanen hochdosierten Strahlentherapie bei Patienten mit Oligometastasen eines kastrationsresistenten Prostatakarzinoms.
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Tobias Hölscher
Registration
NCT04141709

Title
Vergleich von Protonen- und Photonentherapie von Hirntumoren: Effizienz und Nebenwirkungen bei klinischen Standarddosen
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof Dr. med. Mechthild Krause
Registration
NCT02824731

Title
Protonentherapie von Tumoren des Kopf-Hals-Bereiches: Prospektive Erfassung von Effizienz und Nebenwirkungen bei klinischen Standarddosen.
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof Dr. med. Mechthild Krause

Title
A pragmatic observational cohort study to evaluate radical radiotherapy for oligo-metastatic cancer patients
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Annekatrin Seidlitz
Description
The objective of E²-RADIatE is the collection of real-world data of cancer patients treated with radiotherapy, to support radiotherapy research and to provide evidence of the role of radiation oncology in a multidisciplinary approach. E²-RADIatE is open ended.

Title
Image-guided focal dose escalation in patients with primary prostate cancer treated with primary external beam hypofractionated stereotactic radiation therapy (HypoFocal-SBRT). A prospective, multicenter, randomized phase III study.
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Tobias Hölscher
Registration
DRKS0002291
Description
The aim of this prospective, randomized, multicenter phase III study is the personalization of RT for patients with primary PCa based on individual tumor geometry derived from modern imaging techniques (mpMRI and PSMA-PET/CT). In the experimental (arm A) simultaneous RT dose escalation to the ITM will be performed under strict adherence to the organs at risks’ dose constraints by using SBRT (ultra-hypofractionated radiation therapy) in a shorter treatment time (5 fractions vs. 20 fractions). In the control arm (arm B) the entire prostatic gland will receive a homogeneous moderately hypofractionated RT according to the current guidelines. RFS after RT (calculated from randomization) will be assessed as the primary endpoint as well as toxicities and patient reported quality of life as secondary endpoints. For the patients in the experimental arm we expect a significant benefit in relapse free survival (from 80% to 90% at 5 years). The improvement in relapse free survival could increase the metastatic free survival, prostate cancer survival and overall survival in high risk PCa patients. Considering the epidemiological importance of the PCa these results could have a significant socio-economic impact. In parallel a translational research program will address the identification of novel biomarkers/bio-imaging-markers predictive for outcome after RT. Furthermore, involvement of patient representatives includes information about the studies status and contributes to patient empowerment. These aspects will facilitate the evolution from an individualized RT to a personalized RT.

Title
Protonentherapie bei Kindern: Prospektive Erfassung von Effizienz und Nebenwirkungen bei klinischen Standarddosen
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Chiara Valentini

Title
Adjuvant stereotactic fractionated radiotherapy to the resection cavity in recurrent glioblastoma
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof Dr. med. Mechthild Krause
Registration
NCT02715297
Description
The purpose of the trial is to compare an adjuvant fractionated stereotactic radiotherapy to the resection cavity after complete resection of a recurrent glioblastoma to observation after this surgery. The aim of the study is to compare progression free survival as a primary endpoint, and overall survival, toxicity and safety as secondary endpoints. Focus of the analysis is to evaluate the change in progression free survival by fractionated stereotactic radiotherapy to the resection cavity. Therefore, the aim of the trial is to evaluate the improvement in outcome due to glioma cell reduction by radiotherapy around the resection cavity. No systemic therapy is part of the protocol. If deemed to be advantageous, systemic therapy or Tumor Treatment Fields (TTFields) can be prescribed regardless to the treatment arm at best investigators choice. Concurrent systemic therapy is not an exclusion criteria for this study.

Title
Protonentherapie von Hirntumoren: Prospektive Erfassung von Effizienz und Nebenwirkungen bei klinischen Standarddosen.
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof Dr. med. Mechthild Krause

Title
Pilotstudie zur Evaluierung der Bildqualität für Tumorkonturierung und Tumorvolumetrie in einem MR-Tomograph niedriger Feldstärke (EBiSaUM)
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof. Dr. med. Dr. Esther Troost

other systemic therapies

Title
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT04895709
EudraCT-number
2021-001188-26
Description
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Title
A Phase 1, Open-label, Multicenter Study of ZW171 in Participants With Advanced or Metastatic Ovarian Cancer, Non-small Cell Lung Cancer (NSCLC), and Other Mesothelin Expressing Cancers
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT06523803
EudraCT-number
2024-511119-11
Description
This study is being done to find out if ZW171 is safe and can treat participants withadvanced (locally advanced [inoperable] and/or metastatic) mesothelin-expressing cancers.

Title
A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05639751
EudraCT-number
2022-502850-14
Description
This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participantswith advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutationand/or deletion. The purpose of this study is to evaluate the safety, tolerability,pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combinationwith docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule,and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) tobe used in subsequent development of PRT3789.

Title
A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT06586515
EudraCT-number
2024-516440-25
Description
The main purpose of this study is to assess safety & tolerability and antitumor activityof LY3962673 as monotherapy and in combination with other chemotherapy agents inparticipants with KRAS G12D-mutant advanced solid tumor types. The study is expected tolast approximately 5 years.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
For the treatment chronic graft-versus-host disease (cGvHD) in adult patients after failure of at least two previous lines of systemic therapy

Title
A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. Johannes Schetelig
Registration
NCT05006716
EudraCT-number
2022-502157-33
Description
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safetyexpansion of selected doses, and a Phase 2 (expansion cohorts)

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
EMBrACE - Patient empowerment through competence: Achieving health beyond the absence of cancer.

Title
A Phase 1 first-in-human study evaluating safety, pharmacokinetics and efficacy of ABBV-706 as monotherapy and in combination with budigalimab (ABBV-181), carboplatin, or cisplatin in adult subjects with advanced solid tumors.
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05599984
EudraCT-number
2023-504598-18
Description
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade

Title
A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer
Phase
phase II
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. Christian Thomas
Registration
NCT03547973
EudraCT-number
2018-001167-23
Description
The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de

Title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4582157
Contact E-Mail-Address
UroStudienKoordination@ukdd.de
Examiner
Dr. med. Elena Abbate
Registration
NCT05794906
EudraCT-number
2022-501343-33
Description
Researchers are looking for a better way to treat men at high-risk of biochemicalrecurrence (BCR) of prostate cancer.BCR means that in men who had prostate cancer and were treated by either surgery and/ orradiation therapy, the blood level of a specific protein called PSA rises. PSA is amarker of prostate cancer cells activity. The PSA increase means that the cancer has comeback even though conventional imaging such as computed tomography (CT) scans, magneticresonance imaging (MRI) and bone scans does not show any lesion of prostate cancer.Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA]positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostatecancer lesions not detectable by conventional imaging. Men with BCR have a higher risk oftheir cancer spreading to other parts of the body, particularly when PSA levels raised toa certain limit within a short period of time after local therapies. Once the cancerspreads to ot

Title
Multizentrische prospektive Studie zu einem randomisierten Vergleich von Carboplatin mit Cisplatin bei extrakraniellen malignen Keimzelltumoren
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. med. Judith Lohse
Description
A randomized comparison will be conducted to determine whether the efficacy of carboplatin is non-inferior to that of cisplatin in the treatment of intermediate, high or very high risk malignant germ cell tumors in terms of event-free survival (EFS).

Title
Safety, Tolerability and Feasibility of Treatment with GP120-activated Regulatory T cells (ATreg) Early After Haematopoietic Stem Cell Transplantation (HSCT) to Reduce the Incidence and Severity of Acute Graft vs Host Disease (GvHD)
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
EudraCT-number
2021-006490-32
Description
The aim of the study is to explore the safety and feasibility of a Treg-based approach as an adjunct immunosuppressive treatment for HSCT recipients early after HSCT. The goal is to prevent the development of acute GvHD, to moderate the severity and to reduce the need for pharmacologic immunosuppression, most specifically the exposure towards steroids, and thus the immunosuppressive burden after HSCT, which exposes recipients to relevant morbidity and potentially mortality.

Title
A Phase I trial to establish the safety and maximum tolerated dose of high-affinity autologous BCMA- targeting CAR T-cells in patients with relapsed and refractory B-cell malignancies CARLOTTA01
Phase
phase I
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. habil Martin Wermke
EudraCT-number
2022-502831-20
Description
A Phase I trial to establish the safety and maximum tolerated dose of high-affinity autologous BCMA- targeting CAR-T cells in patients with relapsed and refractory B-cell malignancies

Title
Cross-institutional, prospective, open label, single group basket study of combined CRAF and MEK inhibition in advanced-stage malignancies harboring BRAF mutations with impaired kinase activity
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4585119
Contact E-Mail-Address
ctc-trialsite@ukdd.de
Examiner
Dr. med. Christoph Heining
EudraCT-number
2018-003237-16
Description
Cross-institutional, prospective, open label, single group basket study of combined CRAF and MEK inhibition in advanced-stage malignancies harboring BRAF mutations with impaired kinase activity

Title
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors.
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05800964
EudraCT-number
2022-502867-39
Description
The primary objective of this study is to: Evaluate the safety and tolerability of AMG 305 in adult participants Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose Determine the recommended phase 2 dose (RP2D)

Title
Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer) – a partially double-blinded, multicenter, randomized, controlled superiority study
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. Theresa Link
Registration
NCT05658172
Description
This is a partially double-blinded, multi-center, randomized, controlled superiority study to evaluate the potential benefits of intensified surveillance versus standard surveillance in medium-risk and high-risk early breast cancer patients. 3500 patients will be randomized in a 1:1 ratio after completion of primary antitumor therapy (adjuvant chemotherapy, surgery or radiotherapy, whichever occurs last) to receive: - Standard Surveillance according to national guidelines or - Intensive Surveillance

Title
Randomized, multicenter, open-label, Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRa-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab (GLORIOSA)
Legal foundation
Medizinproduktegesetz
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT05445778
Description
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRa). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRa positivity by the Ventana FOLR1 Assay.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
Optimization of aftercare following innovative cell therapies

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
Longitudinal, App-based Assessment of Varying Red Blood Cell Transfusion Strategies and their Association with Patient-Reported and Clinical Outcomes in Lower-Risk MDS Patients

Title
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients with Recurrent and/or Refractory Solid Tumors.
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05958121
EudraCT-number
2022-503133-54
Description
The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors. Primary objectives: To determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I) To characterize the safety and tolerability of IMA402 (Phase I/II) To evaluate anti-tumor activity of IMA402 (Phase II) Secondary objectives: To evaluate the initial anti-tumor activity of IMA402 (Phase I) To evaluate anti-tumor activity of IMA402 (Phase II) To describe the PK of IMA402 (Phase I/II)

Title
This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT06743126
EudraCT-number
2024-517062-42
Description
This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma

Title
First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
Phase
phase I
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT06043817
EudraCT-number
2023-506759-51
Description
Study STX-721-101 is an open label, Phase 1/2 study evaluating the safety, tolerability,pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721 inparticipants with non-small cell lung cancer (NSCLC) carrying EGFR/HER2 exon 20 insertion(ex20ins) mutations.

Title
Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours Futibatinib in subjects with FGFR-aberrant solid tumours
Phase
phase II
Legal foundation
Arzneimittelgesetz
Examiner
Dr. med. Christoph Heining
Registration
NCT03767075
EudraCT-number
2017-005108-89
Description
Part A includes a molecular profiling program for subjects with advanced solid tumors (iPROFILER) and a molecular tumor board to select the most appropriate treatment based on the molecular alterations found in the iPROFILER. Part B includes iBASKET, a modular investigator-initiated basket study for subjects with selected molecular alterations.The current protocol contains the Module 2 of iBASKET with the following arms: o Arm 2A: Known pathogenic FGFR1-3 mutations. o Arm 2B: Variants of unknown significance in FGFR1-3 with functional relevance or pathogenic FGFR4 mutations.o Arm 2C: Highly amplified FGFR1-3 (NGS based CN >= 6) WITH high FGFR1-3 mRNA (above the percentile 95 for general cancer population by using Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer) Arm 2D: Highly amplified FGFR1-3 (NGS based CN >= 6) WITHOUT high FGFR1-3 mRNA (above the percentile 95 for general cancer population by using Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer)

Title
Phase I/II First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants with Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Resistant to EGFR Tyrosine Kinase Inhibitors (TKIs).
Phase
phase I/II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT06567015
EudraCT-number
2023-510203-21
Description
The goal of this First-In-Human (FIH) Phase I/II trial is to establish the safetyprofile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK)exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241, amutant selective Central Nervous System (CNS)-penetrant fourth generation EGFR TKI, inparticipants with locally advanced or metastatic NSCLC that progressed during orfollowing third generation EGFR TKI such as osimertinib due to C797X double acquired(secondary) mutations.

Title
A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination with Zanubrutinib or Venetoclax in Participants with Relapsed/Refractory Hematologic Malignancies.
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT05665530
EudraCT-number
2022-502672-23
Description
A Phase 1 Study of PRT2527 as Monotherapy and in Combination with Zanubrutinib or Venetoclax in Participants with Relapsed/Refractory Hematologic Malignancies.

Title
Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Relapsed and/or Refractory Solid Tumors (ACTengine IMA203-101)
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Registration
NCT03686124
EudraCT-number
2019-002370-31
Description
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and a biopsy for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA203 product. MANUFACTURING: IMA203 product will be made from the patient's white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203 product infusion to improve the duration of time that IMA203 product stays in the body. The patient will be admitted to the hospital during the treatment. After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously twice daily for 14 days. Since this study involves gene therapy, patients will be monitored throughout the study and for up to a total of 15 years.

Title
A phase 1b, open label, multi-center, dose optimization and dose expansion study to assess the safety and efficacy of DFV890 in adult patients with myeloid diseases.
Phase
phase I
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587566
Contact E-Mail-Address
ectu@ukdd.de
Examiner
Dr. Katja Sockel
Registration
NCT05552469
EudraCT-number
2022-501406-36
Description
Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of two groups evaluating DFV890 in patients with myeloid diseases. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk) myelodysplastic syndromes (LR MDS) and lower risk chronic myelomonocytic leukemia (LR CMML).

Register and supportive Studies

Title
Protokoll für standardisierte diagnostische Prozeduren, Registrierung und Behandlungsempfehlungen für Kinder und Jugendliche mit einer Philadelphia-Chromosom-positiven chronischen myeloischen Leukämie (CML)
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
Description
Patients are usually diagnosed and treated at the GPOH centres (see list) in accordance with the guidelines. Treatment is carried out within the scope of the authorisation with imatinib as well as with the now approved second-generation tyrosine kinase inhibitors, dasatinib and nilotinib. The drugs are not given on a trial basis. The patients are treated independently of the registry (before and after). There are also no disadvantages for current and future therapies as a result of the registry. Since 01.01.2016, the registry has also served to continue a therapy optimisation study closed on 31.12.2015 (follow-up completed at the end of 2020), initially based in Dresden, since the change of study management from 01.04.2018 based in Erlangen. Study arms: None

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
AA-BMF registry study is a non-interventional study in which as much data as possible is systematically collected in order to gain better knowledge of telomeropathy-associated and bone marrow failure diseases (e.g. aplastic anemia). The patient data is recorded centrally. Biomaterial is also collected and stored centrally in a biomaterial bank.

Legal foundation
Berufsordnung
Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
Collection of epidemiological data on AML: age, initial and prognostic factors, subgroup distributions. Incidence and age distribution are compared with the data from the population-based tumor registers. Collection of the most important patient-relevant clinical endpoints (outcomes): recurrence-free survival (RFS)/time to recurrence (TTR), calculation of the cumulative recurrence incidence (CIR) and overall survival (OS)

Title
Primary Tumor Research and Outcome Network
Legal foundation
Berufsordnung
Examiner
Dr. med. Alexander Thomas

Title
LOGGIC-Core-BioClinical Data Bank
Legal foundation
Berufsordnung
Examiner
Dr. med. Claudia Zinke

Legal foundation
Berufsordnung
Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
Non-Interventionel Obersational plan prospective and retrospective data collection on diagnostics, treatment and course of disease of myleodysplastic syndromes in adults

Title
Sarkomregister
Legal foundation
Berufsordnung
Contact
+49 351-2529
Contact E-Mail-Address
Patientenanfrage.nct-ucc@ukdd.de
Examiner
Prof. Dr. med. Jürgen Weitz
Description
Aim of the study Intensive research into biological correlations and their translation into clinical application is continuously working to improve the treatment of malignant diseases. The individual treatment options result from the combination of a detailed biological characterization of the tumour cells and a comprehensive assessment of the condition of the respective patient. You have been diagnosed with a sarcoma or there is a strong suspicion that you have a sarcoma. With this letter we invite you to participate in a research project for the systematic data collection and characterization of sarcoma diseases. The Sarcoma Registry Study is a study that aims to systematically investigate and characterize the biological and clinical aspects of sarcoma diseases. The collection and archiving of clinical data serves the purpose of medical research. Your consent to the use of associated data is voluntary. If you do not wish to participate or wish to withdraw your consent at a later date, you will not suffer any disadvantages as a result. The aim of the sarcoma study is to carry out analyses of the data and samples obtained, but also to make the samples and data obtained available to future projects researching malignant diseases. Translated with DeepL.com (free version)

Legal foundation
Berufsordnung
Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
Collection of epidemiological data on MPN: age, input and prognostic factors, subgroup distribution. Incidence and age distribution are compared with data from population-based tumor registries. Recording of the most important patient-relevant clinical endpoints (outcomes): overall survival (OS) and quality of life using a questionnaire.

Title
Prospektive Studie des HE4-Serumspiegels bei Patienten mit primärem platin-sensitiv rezidiviertem Ovarialkarzinom
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
Prospective Study of HE4 serum Level in Patients with First Platinum Sensitive Ovarian Cancer Relapse -HELP-ER-

Legal foundation
Berufsordnung
Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
Non-interventional observational study for the treatment of acute promyelocytic leukemia (APL). The registry aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with APL. Additionally, a biobanking project for further translational studies is integrated. 

Title
Deutsche Prospektive Registerstudie zur Erfassung der Behandlungspraxis von gynäkologischen Sarkomen in der klinischen Routine
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. med. Ulrich Canzler
Description
German prospective registry study to record the treatment practice of gynecological sarcomas in clinical routine

Title
ALL-BFM-Register zur Erfassung von Daten von Kindern und Jugendlichen mit akuter lymphoblastischer Leukämie
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
Description
The ALL-BFM registry has the primary goal of collecting population-based medical data from children and adolescents with ALL, regardless of participation in a clinical trial. The collection and regular evaluation of the data is intended to contribute to ensuring the quality of structure, processes and results in the diagnosis and treatment of children with ALL in accordance with the guidelines for pediatric oncology (KiOn-RL). This also includes the possibility of analyzes for historical comparison with previous study populations or with ALL cohorts from other study groups.

Title
Bewegungs- und Ernaehrungsintervention bei Ovarialkarzinomen und die Entwicklung eines Versorgungskonzepts und Evaluation in der klinischen Routine.
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
Exercise and nutrition intervention in ovarian cancer – development of a care concept and evaluation in clinical routine (BENITA)

Title
Comprehensive assessment of clinical features, genomics and further molecular markers to identify patients with early breast cancer for enrolment on marker driven trials: early high-risk breast carcinoma.
Legal foundation
Berufsordnung
Examiner
Prof. Dr. med. Pauline Wimberger
Description
COGNITION aims to offer a comprehensive molecular-genetic profiling of the therapy-resistant lesion after neoadjuvant therapy for early high-risk breast cancer patients who present with a residual bulk tumor (non-pCR or high CPS-EG score) after neoadjuvant therapy. This approach allows for an individualised, risk-adapted, biomarker-stratified therapy recommendation following standard post-neoadjuvant therapy in order to decrease the substantial risk of recurrence and metastasis.

Title
Register für Kinder, Jugendliche und Erwachsene mit Osteosarkomen und biologisch verwandten Knochensarkomen (COSS-Register)
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Judith Lohse
Description
The registry is intended to prospectively record socio-demographic and clinical-diagnostic data as well as the course of the disease, treatment and treatment outcome of included patients with osteosarcoma or other defined bone sarcomas over the long-term. The objectives of the COSS registry are based on the objectives of the epidemiological and clinical state cancer registries. Furthermore, the COSS registry has the task of continuously processing data on the occurrence and progression of cancers, including their early stages, and making the collected data available for scientific cancer research. The other objectives of the registry are Obtaining information on diagnosis, treatment and disease progression of osteosarcomas and other defined rare bone tumour diseases Gaining knowledge about patient characteristics and prognosis of the disease Research into the causes of the disease and identification of (influencing) risk factors Expansion of the database for clinical and translational research on these entities as a platform for information transfer and further development of a network for interdisciplinary collaboration Long-term tracking of disease progression in collaboration with specific research groups Mapping the reality of care and its changes Use as a recruitment framework (sampling frame) for clinical phase II, phase III or therapy optimisation studies.

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
The Registry of the European Mantle Cell Lymphoma Network (EMCL-R) Descriptive, non-interventional pro- and retrospective analysis

Title
International HIT-MED Registry: For children, adolescents, and adults with medulloblastoma, ependymoma, pineoblastoma, CNS-primitive neuroectodermal tumours
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Claudia Zinke
Description
International HIT-MED Registry: For children, adolescents, and adults with medulloblastoma, ependymoma, pineoblastoma, CNS-primitive neuroectodermal tumours

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
The OSHO Myeloma Working Party Registry is intended to map treatment reality, treatment effectiveness and treatment side effects in patients with MM diagnosed in the main OSHO area of activity.

Title
INFORM – INdividualized Therapy FOr Relapsed Malignancies in Childhood
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Claudia Zinke
Description
Recurrent tumours or tumours that have progressed under therapy with a diagnosis of ALL-HR, ALL post-SCT, AML, rhabdoid tumours, ependymoma, medulloblastoma, Ewing's sarcoma, high-grade glioma, high-risk neuroblastoma, non-Hodgkin's lymphoma, osteosarcoma and soft tissue sarcoma. Primary disease of a high-grade glioma (incl. DIPG), a specific soft tissue sarcoma or ETMR without a curative treatment option. In exceptional cases, ‘other’ paediatric refractory or progressive/relapsed entities, including rare tumour diseases, can be included in the registry after consultation with the INFORM Trial Office (and in the case of a rare tumour disease with the GPOH STEP Registry, in the case of nephroblastoma, hepatoblastoma, retinoblastoma, malignant endocrine tumours or germ cell tumours with the respective GPOH study group). The principle of the INFORM programme is to characterise tumour samples obtained from routine biopsies using state-of-the-art molecular genetic methods as precisely as possible today, regardless of the diagnosis, in patients with relapse or progression of the malignant disease for whom no established treatment concept is available. From such a ‘fingerprint’ of the tumour, a panel of experts (experienced paediatric oncologists, bioinformaticians, biologists, pharmacologists) will then classify the changes found for each individual patient according to clinical relevance. This molecular information should be available in less than 4 weeks. Within the framework of the registry, no therapy recommendations are made, only the molecular information - the treating physician has access to the biological information obtained on his patient and bears full responsibility as to whether and in what form he uses it for his therapy decision.

Title
Register AML-BFM 2017
Legal foundation
Berufsordnung
Examiner
Tobias Däbritz

Title
Multizentrisches Register für Kinder und Jugendliche mit Kraniopharyngeom, Xanthogranulom, Zysten der Rathkeschen Tasche, Meningeom, Hypophysenadenom, Arachnoidalzyten
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Claudia Zinke
Description
The registry collects data and provides advice. Therapy should be carried out in accordance with the standard of care. Collection of epidemiological data Collection of information on treatment and treatment outcome and retrospective evaluation of the relationship between intervention and outcome Recording of late effects Assessment of the quality of treatment through data collection, data review and consultation by the registry centre and the reference institutions Creation of a tumour bank as a basis for future biological research projects to identify new risk factors and targets for targeted therapeutics.

Title
Establishing thresholds for clinical importance for disease-specific EORTC questionnaire modules
Legal foundation
Berufsordnung
Contact
+49 351-45819057
Contact E-Mail-Address
martin.eichler@ukdd.de
Examiner
Dr. Martin Eichler
Description
Background: Patient-reported outcomes (PROs) are often difficult to interpret for untrained persons. For their use in routine clinical practice, thresholds are needed that simplify the interpretation of the results for users. For one of the world's most frequently used PRO-instruments in the field of oncology (the EORTC QLQ-C30), such threshold values were determined in a previous research project in relation to the clinical significance of the information collected. Such thresholds are not yet available for the entity-specific supplementary modules of the QLQ C30. Objective: To determine thresholds for the clinical importance of PROs for entity-specific EORTC questionnaires. Approach: Questionnaire study. The symptoms/functional limitations of patients and so-called anchor items that record the clinical significance of the symptoms/functional limitations are collected. Conclusion: Threshold values for the clinical significance of a total of 8 EORTC questionnaire modules will be developed. The University Hospital Dresden is involved in determining the threshold values for the QLQ-EN24 (endometrium) and the QLQ-OV28 (ovarian cancer).

Title
Seltene Tumorerkrankungen in der Pädiatrie STEP Register. Register zur Verbesserung der epidemiologischen und klinischen Erfassung von Kindern und Jugendlichen mit besonders seltenen Tumoren.
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
Description
Comprehensive prospective clinical data collection of particularly rare tumours in children and adolescents for a more precise definition, characterisation and classification of rare tumour entities, including long-term follow-up Provision of clinical data for retrospective subgroup analyses as part of research projects in order to contribute to improving the quality of diagnosis and treatment of children and adolescents with particularly rare tumour diseases Support for translational research projects Further development of the network for interdisciplinary cooperation in the field of rare tumours Expansion of international co-operation Cooperation with other GPOH registries, including the MET registry, the GPOH cancer predisposition registry and the INFORM registry Translated with DeepL.com (free version)

Title
Register für Lebertumoren bei Kindern und Jugendlichen
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
Description
Primary liver tumours in children and adolescents are rare and affect 0.3-1% of all paediatric tumours. In Central Europe, the incidence is 0.5-2 cases per 1 million children. The most common tumours are hepatoblastoma (HB) in infants and young children and hepatocellular carcinoma (HCC) in schoolchildren and adolescents. Malignant, non-epithelial tumours from the group of sarcomas, as well as germ cell tumours, rhabdoid tumours and others are much rarer. The liver tumour register aims to comprehensively register all children, adolescents and young adults suffering from benign or malignant liver tumours in Germany. Special emphasis is placed on the collection of comprehensive epidemiological data, the documentation of therapy, the recording and checking of the function of the reference structures and the preservation of tumour and patient material in a GPOH tumour bank. Objectives Epidemiology: Expansion of knowledge on the following epidemiological aspects of primary liver tumours in children and adolescents in addition to the data recorded in the IMBEI (see initial IMBEI report): Frequency, age distribution, familial burden and genetic predisposition, associated diseases and infections, tumour symptoms, tumour status at diagnosis, histology and disease progression (survey questionnaire, questionnaire on follow-up care / late effects, histology questionnaire) Health services research: recording and review Translated with DeepL.com (free version)

Title
Prospective Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcome Data in Ovarian Cancer Patients Eligible for First-line Platinum-based Chemotherapy and Intended for BRCA/HRD Testing
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT04830709
Description
This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on: - outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured, - patient's follow-up (FU) during and after MTX therapy, - patient-reported outcomes (PROs), experiences and needs, - physician's experience, - BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy, - patient selection for different 1L systemic treatment approaches, - use and safety of drugs, - treatment sequence in case of recurrence

Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
Collection of data on the epidemiology, treatment and disease progression of ITP in adults in routine clinical practice, regardless of whether the patient is being treated within a clinical therapy trial or not. The aim here is to test the hypothesis as to whether the therapy sequence has an influence on the remission - in particular on the therapy-free remission.

Title
Internationales Molekulare Neuropathologie Register
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Claudia Zinke
Description
The constantly growing diversity of CNS tumour types in childhood and adolescence is reflected in extremely different disease progressions, and the rarity of individual tumour types and their varying appearances often make diagnosis difficult. However, the correct classification of CNS tumours is of paramount importance for the selection of the optimal treatment strategy for each patient. In order to increase diagnostic accuracy and thereby support accurate classification, MNP Int R will investigate CNS tumours at the time of initial diagnosis using molecular genetic analysis methods. Primary objectives Establishment of comprehensive molecular diagnostics Establishment of an international register for molecular diagnostic data Integration of neuropathological reference diagnosis, radiological reference findings and molecular genetic results in a multi-layered diagnosis Further development of DNA methylation-based CNS tumour classification Correlation of molecular diagnostic parameters with clinical disease progression Analysing the collected data Provision of data and assistance in the interpretation of molecular genetic information for clinicians, patients and their parents, as well as scientists

Title
HIT-LOGGIC Register: Prospektives multizentrisches Register für Kinder und Jugendliche mit einem niedrig-gradigen Gliom
Legal foundation
Berufsordnung
Examiner
Dr. med. Claudia Zinke

Title
Eine prospektive Registerstudie der Universitätsfrauenklinik Magdeburg in Zusammenarbeit mit den klinischen Krebsregistern zur Diagnostik und Therapie des Mammakarzinoms des Mannes
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
A prospective registry study of the University Women's Hospital Magdeburg in collaboration with the clinical cancer registries on the diagnosis and treatment of male breast cancer

Title
PROSPECTIVE ACADEMIC TRANSLATIONAL RESEARCH NETWORK FOR THE OPTIMIZATION OF THE ONCO­LOGICAL HEALTH CARE QUALITY IN THE ADJUVANT AND ADVANCED/METASTATIC SETTING: HEALTH CARE RESEARCH, PHARMACOGENOMICS, BIOMARKERS, HEALTH ECONOMICS
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Registration
NCT02338167
EudraCT-number
2014-­-000854-­-12
Description
PRAEGNANT - Prospective Academic translational research network for the optimization of oncological health care quality in the advanced setting. This german study network was set up to take account of some of the recent developments in molecular medicine in the treatment of patients with metastatic breast cancer. It is an academic registry and translational diagnostics study with the aim to build a healthcare research data base with the objective: to carry out molecular tests under study conditions to identify suitable breast cancer patients for clinical trials based on molecular testing to identify breast cancer patients suitable for clinical trials based on conventional inclusion criteria to record treatment-induced toxicities and patient´s quality of life in routine clinical practice to record, show and benchmark the reality of medical care provided to patients with advanced/metastatic breast cancer

Title
Health-related quality of life measurement strategy for solid rare cancers
Legal foundation
Berufsordnung
Contact
+49 351-45819057
Contact E-Mail-Address
martin.eichler@ukdd.de
Examiner
Dr. Martin Eichler
Description
This projects’ overarching goal is to improve HRQoL measuring practices for individuals with solid rare cancer diagnoses. Due to the diversity of tumours, therapies and patient experiences, it will be hard to develop a single HRQoL score for all rare malignancies. Understanding these variations is crucial when developing an HRQoL measuring technique. Such a measurement strategy will ensure that future research and clinical practice capture the most important outcomes to patients with rare cancer.

Title
ALL-REZ BFM-Beobachtungsstudie und Biobank für Rezidive einer akuten lymphoblastischen Leukämie im Kindes- und Jugendalter
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
Description
By recording all children and adolescents with an ALL recurrence as completely as possible in a register, epidemiological statements can be made about the incidence, course and prognosis of children with ALL recurrence. This group contributes more than any other to the mortality of children with malignant diseases. Patients can be systematically followed up, late effects recorded and correlated with previous therapies and clinical factors. Corresponding risks can be taken into account in future therapy strategies. As a competence centre for relapsed/refractory ALL, the study centre can advise participating centres on specific questions regarding individual therapy strategies as well as radiation and transplantation indications. Patients with relapsed and/or refractory ALL can be counselled regarding treatment in an open AMG study and assigned accordingly. The treatment instructions enclosed with this protocol do not represent recommendations for a generally recognised treatment in this specific form and combination, but are rather guidelines for treatment. The risk groups S1 to S4 are categorised according to the definition of the ALL-REZ BFM 2002 study. The only change to this classification is the categorisation of very early isolated extramedullary recurrences in the S4 group. Due to the good results of the ALL-REZ BFM 2002 study, treatment according to the ALL-REZ BFM 2002 protocol is still recommended for children and adolescents with first ALL recurrence until the start of the new international ALL recurrence study. Consolidation is carried out with protocol II-Ida. In the event of a subsequent relapse, consultation with the study centre is recommended.

Title
International CPT-SIOP-Registry
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Claudia Zinke
Description
The registry does not conduct drug trials within the meaning of the AMG. It provides advice based on the interim results of the CPT-SIOP-2000 study. This shows that patients with plexus carcinomas in particular can benefit from chemotherapy and, if not contraindicated by age, radiotherapy after the greatest possible removal of the tumour. Until a follow-up study is opened, patients with plexus tumours can be registered in this registry. Treatment is at the discretion of the responsible physician. Choroid plexus tumours are very rare brain tumours in which the choroid plexus in the ventricles of the brain begins to proliferate. They account for around half a percent of all brain tumours across all age groups. However, as they usually occur at an early age, the overall proportion in children is significantly higher at 1 to 4%, and even up to 13% in the first year of life. In Germany, around 10 patients a year have been reported in recent years. A distinction is made between benign plexus papillomas, malignant plexus carcinomas and, in the middle position, atypical plexus papillomas, all of which occur with approximately the same frequency. Some plexus carcinomas are caused by Li-Fraumeni syndrome, an autosomal-dominantly inherited tumour predisposition in which the tumour suppressor gene TP53 is usually altered. Furthermore, the expression and copy number of one of the genes for PDGF receptors is often increased. After completion of the CPT-SIOP-2000 therapy study, which is currently in the evaluation phase, and before the opening of a follow-up study in Germany and other countries, the registry will be open to all patients with plexus tumours. In view of the rarity of the tumours, it is still desirable for the best possible data quality that all patients are recorded as completely as possible worldwide.

Title
Rhabdoide Tumoren jeglicher anatomischen Lokalisation
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Prof. Dr. med. Ralf Knöfler
Description
Rhabdoid tumours are rare, highly aggressive and often unfavourable tumour diseases that occur primarily in infants and small children. Due to their rarity, there is little reliable data in the medical literature on frequency, causes and promising standardised treatment approaches. Most published studies consist of small case series or a summary of case reports. Genetics The group of rhabdoid tumours (irrespective of the anatomical location) have a change in the SMARCB1 gene (hSNF5/INI1) on chromosome 22 in common. To detect this alteration, both immunohistochemical examinations of the tumour tissue and genetic examinations of tumour and blood cells of the affected patients are carried out. In rarer cases, a germline mutation can be detected. Genetic testing of the parents and possibly other family members is then advisable. Frequency According to our own survey, around 30-40 children in Germany are diagnosed with rhabdoid tumours every year. Similar figures are recorded in other comparable European countries. At a consensus conference of European representatives of the SIOP Brain Tumour Committee and Italian and German representatives of the soft tissue sarcoma and nephroblastoma groups in Genoa in January 2007, it was decided to create a joint rhabdoid tumour register. The aim of the European Rhabdoid Tumour Registry is to collect complete clinical, molecular genetic and therapy-related data on all patients with rhabdoid tumours of the brain (AT/RT), kidneys (RTK - rhabdoid tumour kidney) and soft tissue (MRT - malignant rhabdoid tumour) in Europe.

Title
Registry for neonates, infants, children, adolescents, and adults with newly diagnosed and/or relapsed neuroblastic tumors (NB Registry 2016)
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
Description
The demographic NB Registry 2016 serves as a superordinate database to enable: a standardised diagnosis, a central reference assessment of tumour samples, bone marrow and imaging to assess the spread of the tumour (staging), a standardised molecular baseline analysis, the collection of biomaterials, the correlation of molecular and clinical data, a long-term follow-up, the allocation of patients to early clinical trials, international cooperation

Title
Versorgungsoptimierung für Frauen mit einer erblichen Belastung für Brust- und Eierstockkrebs durch ergebnisorientierte Evaluation der präventiven Maßnahmen
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. med. Karin Kast
Description
The aim ist to bring the women with high fraught with risk into a accompanied intensive screening program, so that the emphasis be placed on earliest diagnosis malignant processes and participation in prevention-oriented studie

Legal foundation
Berufsordnung
Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
The aim of the GMALL registry is to collect data on the diagnosis, treatment and disease progression of ALL in patients 18 years of age with no upper age limit in routine clinical practice, regardless of whether the patient is being treated within a clinical therapy trial or not.

Title
Genetic and Immunological Characterization of Acquired Severe Aplastic Anemia (SAA) in Children and Adolescents
Legal foundation
Berufsordnung
Examiner
Tobias Däbritz
Description
Genetic and Immunological Characterization of Acquired Severe Aplastic Anemia (SAA) in Children and Adolescents An open non-randomized multi-center prospective study

Title
Prospektive und retrospektive Registerstudie zur Diagnostik und Therapie des Mammakarzinoms in der Schwangerschaft
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Dr. med. Cornelia Meisel
Registration
NCT00196833
EudraCT-number
2007-002841-19
Description
Breast cancer in Pregnancy (BCP)Prospective and Retrospective Registry Study of the German Breast Group (GBG)for Diagnosis and Treatment of Breast Cancer in Pregnancy compared to young non-pregnant women

Title
„Caroline meets HANNA – Holistic Analysis of LoNgterm-survival with OvariaN Cancer
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
The study “Carolin meets HANNA” by the North-East German Society for Gynecological Oncology (NOGGO e.V.) aims to change this and examines long-term survivors of ovarian cancer. The intention of the two-part study is to identify factors that characterize this exceptional group of patients.

Title
Development of a Module to Assess the Patients' Financial Burden Related to Cancer Treatment - Phase I
Legal foundation
Berufsordnung
Contact
+49 351-45819057
Contact E-Mail-Address
martin.eichler@ukdd.de
Examiner
Dr. Martin Eichler
Description
The financial impact of cancer on the individual patient is often characterised as an objective and a subjective financial burden. The objective financial burden gives no information on how the patient himself perceives the financial impact and the consequences on his life; this view is provided by the subjective financial burden, which describes the impact and consequences of the objective costs on the patient. This often results in material consequences, psychological effects, or behavioural changes, which then are expressed as a “financial toxicity”. The currently existing tools are either only narrowly validated, are generic economic tools, are restricted to a certain health care system, are restricted to a specific cancer site, or do not cover all relevant domains of financial toxicity. The aim of this Phase I study is to develop a list of issues related to financial toxicity in cancer patients.

Title
Characteristics related to Assessments of disease, patient and treatment associated with long-term survival in ovarian cancer patients (CAROLIN)- Intergroup study NOGGO / A-AGO
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
In this Non-interventional study (NIS) patients with platin-sensitive relapsed ovarian cancer (OC) will be included who are eligible for Niraparib treatment (treatment decision by physician independently before inclusion of the patients into the study). The Niraparib treatment will be according to SmPC. During the NIS study data will be collected at baseline, every 3 months during Niraparib treatment and every 6 months during up to 7 years of follow-up (long term survival) or patient’s death whatever comes first.

Title
Auswahl patientenrelevanter Symptome zur Entwicklung entitätsspezifischer PRO-CTCAE-Fragebögen für Patienten mit Sarkom oder GIST
Legal foundation
Berufsordnung
Examiner
Dipl. Psych. Leopold Hentschel
Description
You are currently being treated for cancer at Dresden University Hospital. In a research project, we are developing questionnaires to find out how much cancer patients are affected by the side effects of their treatment. In future, the questionnaires should help us to further develop measures for the earliest possible detection and treatment of side effects.

Title
Register zur Erfassung maligner endokriner Tumoren im Kindes- und Jugendalter
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
Description
Recommendations on the diagnosis, treatment and aftercare of malignant endocrine tumours in children and adolescents are not part of the new MET Registry (protocol). For the entities covered by the MET registry (ACT, DTC, MTC, NET, PPGL), the physicians responsible for their treatment are provided with published national recommendations on diagnosis and treatment based on current knowledge and current analyses of the MET registry, which are not part of the registry protocol. A European recommendation is already available for the entity of ACT (Virgone, C., et al., Pediatr Blood Cancer, 2021). If required, a patient-specific counselling request can be submitted to the MET Help Desk. For this purpose, a corresponding declaration of consent must be obtained from the treating clinic for the respective patient (aged 16 and over) and/or their legal guardian. Translated with DeepL.com (free version)

Legal foundation
Berufsordnung
Contact
+49 351-45818380
Contact E-Mail-Address
sal-aml-register@ukdd.de
Description
National Clinical Amyloidosis Registry

Title
Krebsprädispositionssyndrom-Register 01
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
Description
Over 50 hereditary diseases are known to be associated with an increased risk of cancer. For many of these diseases, little is known about the specific cancer risk. For some diseases, it seems to make sense to carry out early detection tests due to the high risk of cancer. However, little is known about the benefits of these examinations. In addition, the hereditary basis of cancer development and the changes in the tumour cells of those affected have not yet been sufficiently researched. It can be assumed that a significant proportion of all patients with cancer develop it due to a genetic predisposition. There are various unanswered questions for patients with cancer predisposition syndromes: What is the benefit of expert-recommended screening? Are there genotype-phenotype correlations? How high are the cancer risks in different age groups? What is the prognosis of cancer in patients with a genetic predisposition to cancer? What particular side effects of therapy occur? How can the treatment of people with a cancer predisposition be improved? What are the biological processes that lead to the development of cancer?

Other clinical trials

Title
Response prediction of neoadjuvant therapy in advanced pancreatic cancer (Neo-Response-Trial) Prädiktion des Ansprechens auf eine neoadjuvante Therapie des fortgeschrittenen Pankreaskarzinoms
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Daniel Stange
Description
The aim of this scientific investigation is to identify biological factors (biomarkers) that allow the effectiveness of drug therapy to be predicted. The means that the tumour of the pancreas can be treated with molecular biological methods (in in the broader sense: laboratory tests) is examined in order to be able to make a decision in the future before the administration of therapy to predict whether the therapy has a good chance of having an effect or whether other therapy (e.g. other chemotherapy) should be used.

Title
Clinical Research platform Into molecular testing, treatment and outcome of non-Small cell lung carcinoma Patients (AIO-TRK-0315)
Legal foundation
Berufsordnung
Registration
NCT02622581
Description
Clinical Research platform Into molecular testing, treatment and outcome of non-Small cell lung carcinoma Patients (CRISP)

Title
UMBRELLA PROTOCOL SIOP-RTSG 2016
Phase
phase IV
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Julia Franck
EudraCT-number
2016-004180-39
Description
The study contains treatment recommendations for the treatment of wild-type renal tumours, other renal tumours and metastatic and recurrent renal tumours. The treatment recommendations are based on the results of the previous SIOP 2001 study. No new study questions were asked in SIOP 2016.

Title
Evaluierung von prompt-gamma-imaging zur Reichweitenverifikation für die Protonenbestrahlung von Tumorpatienten
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Prof. Dr. med. Dr. Esther Troost

Title
Video-Tumorboard PLUS
Legal foundation
Berufsordnung
Contact
+49 351-45817983
Contact E-Mail-Address
heidi.weber@ukdd.de
Examiner
Prof. Dr. med. Friedegund Meier
Description
Optimization of participation in the UKD Tumorboard for external medical institutions, including the offer of supplementary measures for patients presented in the case discussion.

Title
Internationales Euro Ewing-Register
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Judith Lohse
Description
Objective: Collection of long-term follow-up data that goes beyond clinical trials Collection of data from patients receiving standard treatment if no current clinical trial is available Collection of data from patients who do not fulfil the criteria for clinical trials Therapy/study arms: The International Euro Ewing Registry is a multinational Ewing sarcoma (EwS) registry. It includes all newly diagnosed patients with localised or metastatic EwS who cannot be included in ongoing clinical trials. Patients from clinical trials can also be included in the registry after their completion for long-term follow-up. The registry is also open to patients with so-called ‘atypical EwS’ or ‘Ewing-like sarcomas’. In contrast to the clinical trials, there is no age limit. Biomaterial from registry participants is collected in the GPOH-CESS biobank for accompanying studies, as there is a great need for research into genetic diagnostic and therapeutic approaches. The registry does not provide a treatment plan. If no clinical trial is available, patients are treated according to the standard treatment.

Title
Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Dr. med. Olga Radulova-Mauersberge
Registration
NCT06414031
EudraCT-number
2023-509970-43
Description
The goal of this clinical trial is to learn if the administration of tranexamic acid canreduce the necessity of blood transfusions in adult patients undergoing major abdominalsurgery. It will also inform about safety of tranexamic acid in this setting.The main question it aims to answer is: Does tranexamic acid lower the probability ofreceiving at least one blood transfusion during or after surgery?Participants will compare tranexamic acid o a placebo (a look-alike substance thatcontains no drug) to see if tranexamic acid works to reduce the necessity of a bloodtransfusion.

Title
Nationales Biomarker-Programm für resektable gastrointestinale Stromatumoren (GIST) zur Etablierung und Validierung des Wertes der Liquid Biopsy im Spannungsfeld der klinischen Therapieentscheidungen.
Examiner
Dr. med. Stephan Richter
Description
Cross-Platform Biomarker Program for Establishment and Validation of Liquid Biopsy for Clinical Decision Making in resectable gastrointestinal stromal tumour (GIST)

Title
Randomisierte, multizentrische, offene, Phase III, Äquivalenzstudie (non-inferiority) für Patienten mit Nierentumor des Kindesalters im Stadium IV zum Vergleich der präoperativen Chemotherapie bestehend aus Vincristin, Actinomycin – D und Doxorubicin (VAD, Standardarm) mit der präoperativen Chemotherapie bestehend aus Vincristin, Carboplatin und Etoposid (VCE, Vergleichsarm)
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Prof. Dr. med. Ralf Knöfler
EudraCT-number
2018-000533-13
Description
To demonstrate the non-inferiority of 6 weeks of preoperative chemotherapy with VCE compared to chemotherapy with AVD based on the early overall metastatic response rate (MetRR) in newly diagnosed stage 4 paediatric renal tumours (equivalence test). The MetRR includes the pulmonary response rate (PRR) and the non-pulmonary metastatic response rate (NPRR). The entire clinical trial comprises the 6-week preoperative therapy. This is followed by observation of further treatment, which usually lasts 29 weeks (2 weeks perioperative phase and 27 weeks of therapy).

Title
Incidence and clinical impact of serum HYperamylasemia (POH) after Pancreatectomy on Postoperative Outcome and patient safety
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Marius Distler
Description
A common complication in pancreatic surgery is postoperative pancreatic fistula (POPF), which can lead to serious consequences. There is an international study group addressing this issue and recommending a new definition and classification of postoperative acute pancreatitis. However, there is still no systematic study of the clinical impact and frequency of this complication. This study aims to investigate the relationship between biochemical changes and postoperative morbidity in pancreatic resections. Early detection of abnormalities in laboratory values will allow faster treatment of potential complications and reduce overall morbidity. These values will be collected and validated in each patient over a 12-month period. The main objective of the study is to investigate whether postoperative serum hyperamylasemia (POH) is a predictive value for the severity of postoperative acute pancreatitis (PPAP) based on the new definition of ISGPS. The study also investigates the relationship between POPF and PPAP and the predictive value of biochemical changes for severe postoperative acute pancreatitis. In addition, a clinical score is created based on the variables assessed to predict severe postoperative pancreatitis.

Title
Biologische Charakterisierung und Vergleich von Patienten mit multipel ossär oder lymphogen metastasiertem Prostatakarzinom sowie mit Knochenmetastasen anderer Primärtumoren/ Histologie (Poly-CR-P-Studie)
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Annett Linge

Title
EWOG-MDS 2006: Prospective non–randomized multicenter study for epidemiology and characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leukemia (JMML) in childhood
Legal foundation
Berufsordnung
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
Registration
NCT00662090
Description
Frequency of the different subtypes of MDS in childhood and adolescence by a standardized diagnostic approach plus the relapse rate, morbidity and mortality in children with MDS and JMML treated by HSCT. Therefore the frequency of cytogenetic and molecular abnormalities is analysed, using array-CGH to evaluate the frequency of subtle chromosomal imbalances, using mFISH to identify unknown chromosomal aberrations

Title
Internationale, prospektive “Umbrella”-Studie für Kinder und Jugendliche mit atypischen teratoiden/rhabdoiden Tumoren (ATRT) incl. einer randomisierten Phase III-Studie zur Untersuchung der Nichtunterlegenheit von 3 Kursen Hochdosis-Chemotherapie (HDCT) verglichen mit fokaler Strahlentherapie in der Konsolidierung.
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Claudia Zinke
EudraCT-number
2018-003325-29
Description
Prospective, open label, multicentre, international umbrella study including a randomised phase III trial on the non-inferiority of 3 courses of high-dose chemotherapy compared with focal radiotherapy plus standard chemotherapy in consolidation after conventional induction chemotherapy for children with ATRT aged 12 - 35 months at the time of radiotherapy. Randomised arm Part A To test the non-inferiority, measured by 2-year overall survival, of 3 courses of high-dose chemotherapy (HDCT) compared with focal radiotherapy plus conventional chemotherapy in consolidation after conventional induction chemotherapy for children with ATRT who are 12 - 35 months old at the time of consolidation. Part B (non-randomised) To evaluate the effectiveness, measured by overall survival, of 3 courses of high-dose chemotherapy as a consolidation measure after conventional chemotherapy for induction in children with ATRT who are younger than 12 months at the time of HDCT or who have contraindications to radiotherapy and do not qualify for Part A. Patients are compared with historical controls. Part C (non-randomised) Evaluation of the effectiveness, measured by overall survival, of radiotherapy as a consolidation measure, combined with up to 12 courses of conventional chemotherapy in children =36 months of age or those who have a contraindication to high-dose chemotherapy and do not qualify for Part A of this study. The historical control group serves as a comparison.

Title
Langzeit Beobachtung von Patienten mit malignem Melanom - ein regionales Register für die Versorgungs- und Translationsforschung
Legal foundation
Berufsordnung
Contact
+49 351-45819782
Contact E-Mail-Address
oncostudien.dermatologie@ukdd.de
Examiner
Prof. Dr. med. Jochen Schmitt
Description
Long-term follow-up of patients with malignant melanoma - a regional registry for care and translational research.

Title
Prädiktion des Ansprechens auf Hypertherme Intraperitoneale Chemotherapie in gastrointestinalen Krebserkrankungen
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Daniel Stange
Description
Synchronous peritoneal metastasis in advanced gastric or colon carcinoma is still a devastating diagnosis for the affected patients despite modern therapy methods. This is because not only is the quality of life significantly reduced due to, among other things, passenger disturbances and ileus, but life expectancy is also drastically reduced. Although overall survival can be increased by modern systemic chemotherapy, cure is not possible. As part of a multimodal therapy, a treatment combination consisting of complete surgical resection and perfusion by hyperthermic intraperitoneal chemotherapy (HIPEC) has become established in cases of low-grade PC. It has been shown that a significant increase in overall survival can be achieved with this treatment modality. However, PC recurrence rates of up to 80% are still very high. In addition, despite worldwide use for over 30 years, this treatment method lacks standards as well as patient-specific individualizability. Thus, for PC in colon cancer alone, more than 60 different HIPEC regimens are in use internationally, which so far mainly rely on observational studies or prospective single-arm trials. Thus, PC offers a clinical setting for preclinical drug testing, e.g. using organoid models, to enable optimal treatment tailored to each individual patient in the future. The present exploratory pilot study aims to establish organoid cultures from tumor material for preclinical testing of HIPEC regimens in the form of mono- and combination therapies, thus investigating the predictive value of the organoid model with respect to the efficacy of the HIPEC procedure. In parallel, extensive molecular genetic studies will be performed on the established organoid cultures to identify resistance to systemic neoadjuvant therapy.

Title
Belastungen & Bedürfnisse von Melanom Survivors
Phase
n/a
Legal foundation
Arzneimittelgesetz
Examiner
Prof. Dr. med. Friedegund Meier
Description
Survivorship in Melanoma Cross-sectional study to assess quality oflife, health-status and needs of stage III Melanoma survivors (in an extended/permanent survival period) In Germany

Title
Entwicklung eines berührungsfreien und applikationsfreien Kamerasystems mit kurzwelligem Infrarotlicht zur Detektion von Lymphknoten
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Description
The lymph nodes in the abdominal cavity are located on the vessels that supply the intestines. They resemble the surrounding fatty tissue in shape and appearance and are therefore not easy to recognize and often only with the appropriate experience. The lymph nodes contain significantly more water than the fatty tissue. Because of the higher water content, the lymph nodes can be visualized with infrared light and a special camera without using other aids. without using other aids. The infrared light-sensitive camera system (ITIS) has recently been developed as a prototype. It is intended to make it easier for the examiner to distinguish between lymph nodes and fatty tissue. Whether this method works well must be tested on appropriate tissue.

Title
Bildgebende Verfahren zur Diagnostik von frühen Melanomen bei Hochrisiko-Patienten (MSC)
Legal foundation
Berufsordnung
Contact
+49 351-45812692
Contact E-Mail-Address
peggy.binkenstein@ukdd.de
Examiner
Dr. med. Sarah Hobelsberger
Description
Prospective, unicentric study with the central question of whether the imaging methods total body photography, dermatoscopy and confocal laser microscopy as a supplement to primary skin cancer screening for melanocytic lesions lead to an earlier diagnosis of melanoma. A cohort with regular skin cancer screening with dermatoscopy represents the control group.

Title
Development of a Risk Prediciton Model for Chemotherapy-induced Nausea and Vomiting
Legal foundation
Berufsordnung
Contact
+49 351-4584202
Contact E-Mail-Address
studiensekretariat.gyn@ukdd.de
Examiner
Prof. Dr. med. Pauline Wimberger
Description
This is a prospective, multicentre, non-interventional observational trial performed in 2 stages for patients with primary gynaecological cancer who are requiring chemotherapy Step 1 and 2: In the first step patients will be asked to complete a questionnaire concerning their personal risk factors for nausea and emesis. The actual occurrence of these events will be documented throughout the chemotherapeutic treatment. We will try to find connections between the risk factors and the development of nausea and vomiting with the aim of creating a model for calculating the patient’s personal risk. In the second step of the study this model will be applied to a larger number of patients preceding treatment and its predictive value will be examined.

Title
INTERNATIONAL EURO EWING TRIAL FOR TREATMENT OPTIMISATION IN PATIENTS WITH EWING SARCOMA
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Dr. med. Stephan Richter
EudraCT-number
2019-004153-93
Description
The primary aim and rationale of this protocol are to improve the survival of patients with Ewing sarcoma. iEuroEwing is an overarching protocol with two randomised comparisons addressing therapeutic questions. The primary aim of the iEuroEwing-SR part is to improve EFS by introducing a maintenance treatment with known efficacy in patients with Ewing sarcoma and other small blue round cells sarcomas in a randomised design.

Title
Von Patienten-abgeleitete Lungentumor-Organoide in der Präzisionsonkologie
Legal foundation
Berufsordnung
Contact
+49 351-4587666
Contact E-Mail-Address
oncostudy@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Description
A clinical trial to study the applicability of lung cancer organoids for diagnostic, therapeutic and biologic questions.

Title
nationales Netzwerk genomische Medizin - Lungenkrebs
Legal foundation
Berufsordnung
Contact
+49 351-4587566
Contact E-Mail-Address
nngminfo@ukdd.de
Examiner
Prof. Dr. med. habil Martin Wermke
Description
The National Network Genomic Medicine Lung Cancer (nNGM) centralizes molecular diagnostics for non-small cell lung cancer (NSCLC) throughout Germany for the first time. In this way, a comprehensive genetic analysis of the tumor can be made available to all treatment providers during initial therapy planning. For this purpose, comprehensive molecular diagnostics will be offered in specialized nNGM network centers - subsequent treatment can then take place close to home in an oncology practice or in the local hospital.

Title
Liquid Biopsies für die personalisierte Krebstherapie des Kolon- und Rektumkarzinoms (Kolibri)
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Annett Linge

Title
Internationale kooperative prospektive Studie für Kinder und Jugendliche mit Standardrisiko ALK-positiven ALCL zur Wirksamkeit einer Vinblastin Therapie
Phase
phase IV
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Maria Polacik
EudraCT-number
2017-002935-40
Description
The aim of the study is to prove that it is possible to cure at least 75% of all SR patients with a 24-month monotherapy with vinblastine.

Title
Entwicklung von Therapieentscheidungen anhand von Magenkarzinomorganoiden
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Daniel Stange
Description
By taking blood and tissue samples, tumor cells can be transferred into cell culture models (organoids). Using these organoid models, the response to various therapies as well as changes in the genetic material and cell composition can be analyzed under laboratory conditions. This means that the tumor cells and the genetic material (genes) of the tumor of the esophagus/stomach are examined using laboratory methods in order to enable a more individually effective therapy in the future. The goal of this study is to define alternative therapeutic options when organoid models do not respond to standard therapy for gastric cancer. The current clinical standard is that locally advanced, operable tumors are first treated with drug therapy (chemotherapy, possibly with targeted therapy or antibody therapy) to reduce the size of the tumor, followed by surgical removal of the tumor. Another aspect of the REDESIGN study is to survey the patients, to determine the understanding of the role of organoid models in future precision oncology.

Title
Etablierung von Organoidkulturen von Plattenepithelkarzinomen des Kopf-Hals-Bereiches und des Ösophagus zur Untersuchung des Therapieansprechens und Evaluation von prognostischen Biomarkern.
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Elisa Thomas

Title
Einfluss des Pfortaderdruckes auf das postoperative Leberversagen bei Leberresektionen - eine unizentrische Observationsstudie.
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Carina Riediger-Schweipert
Description
not available

Title
In-vitro-Bindungsanalyse von 18F-markiertem Ivosidenib als neuartiger PET-Tracer für IDH1-mutierte Chondrosarkome und Gliome (Trace-mIDH)
Legal foundation
Berufsordnung
Contact
+49 351-4583777
Contact E-Mail-Address
sarkome@ukdd.de
Examiner
Prof. Dr. med. Klaus-Dieter Schaser
Description
The analysis of the binding specificity of the newly developed tracer is carried out ex vivo on tumor tissue from patients with chondrosarcoma and gliomas and investigates whether the mIDH inhibitor AG-120 labeled with 18F is suitable for the specific visualization of the mutated enzyme in tissue sections. Testing on tissues with different IDH mutations allows the assessment of the binding specificity depending on the respective IDH mutation. The results allow an evaluation of the potential suitability of [18F]AG-120 for non-invasive diagnostics for the localization of an mIDH-positive tumor and potential recurrences/metastases in the patient.

Title
Nivolumab in combination with cisplatin and 5-flurouracil as induction therapy in children and adults with EBV-positive nasopharyngeal carcinoma
Phase
phase II
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Prof. Dr. med. Ralf Knöfler
EudraCT-number
2021-006477-32
Description
Primary study objective The aim of the study is to increase the percentage of patients without metastases who achieve a complete remission on imaging (MRI and PET) after induction therapy. As a result, the radiation dose can be reduced from 59.4 Gy to 54 Gy in patients under 26 years of age with complete remission. Secondary study objectives To evaluate whether nivolumab can be safely used in combination with standard chemotherapy with cisplatin and 5-fluorouracil in children and adults with NPC. To evaluate whether nivolumab can be safely used in combination with radiochemotherapy in patients who have not responded to induction therapy or have metastases.

Title
Analyse von Parametern der Patientenzufriedenheit bei konventionellen versus minimalinvasiven Operationen beim Rektum-, Pankreas- und Oesophaguskarzinom in der Chirurgie
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Dr. med. Olga Radulova-Mauersberge
Description
Surgery often plays a major role in the treatment of abdominal cancer. There are open and minimally invasive abdominal surgery. Depending on the conditions of the individual case, the most suitable surgical method for the patient is selected. The study should contribute to finding out how and by what means operated patients would be satisfied or more satisfied. Furthermore, it is to be determined whether there is a difference in satisfaction depending on the surgical method.

Title
NCT MASTERsg Panelsequenzierung
Legal foundation
Berufsordnung
Contact
+49 351-4585541
Contact E-Mail-Address
master-dresden@nct-dresden.de
Examiner
Prof. Dr. med. Hanno Glimm
Description
The MASTERsg ("subgenomic") program offers, just like the NCT MASTER Program, a comprehensive molecular characterization of our patient's tumors. Using a next generation sequencing-based gene panel, 290 Cancer relevant genes are analyzed and additional information about microsatellite-instability, gene fusions and copy number variations are obtained.

Title
Untersuchung der perioperativen Zusammenhänge zwischen Energiestoffwechsel und Muskelverlust von Patienten mit Krebs des oberen Gastrointestinaltraktes und des Pankreas
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Description
not available

Title
TTFields in general routine clinical care in patients with pleural mesothelioma study
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr, med. Till Plönes
Registration
NCT0553880
Description
Pleural mesothelioma is a rare cancer that is commonly associated with asbestos exposure. Due to the aggressiveness of the disease, the prognosis is very poor. Patients can be treated with different combinations of chemotherapy, surgery and radiotherapy as well as immunotherapy. For early stage pleural mesothelioma, various treatment options can be taken into consideration and there is no consensus on the preferred treatment option. Tumor Treating Fields (TTFields) are low-intensity (1-3 V/cm), intermediate frequency (150 KHz for pleural mesothelioma) alternating electric fields that interfere with cell division. TTFields? anti-mitotic mechanism of action is based on disruption of cell spindle-apparatus by interfering with key electrically charged molecules, such as tubulin or septin proteins that are required for the mitotic process. Interference with these key molecules can lead to cell death through multiple pathways. Pre-clinical studies have shown that TTFields are able to effectively inhibit tumor growth, both, in vitro and in vivo without any systemic side effects. In addition, safety of in vivo TTFields application to the torso was confirmed in a more recent study

Title
Individualisierung der Therapie des Rektumkarzinoms durch Prädiktion des Therapieansprechens auf neoadjuvante Radiochemotherapie mittels Organoidkulturen IndiTRec - Individualized Treatment of Rectal Cancer
Legal foundation
Berufsordnung
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Daniel Stange
Description
The aim of this scientific investigation is to find biological factors (biomarkers) that allow the efficacy of radiochemotherapy and the course of the disease to be predicted. This means that the tumour cells are taken in cell culture and then exposed to the same treatment that you are receiving. In the end, the response of your tumour in the body will be compared with that of the tumour in cell culture. In addition, components of the tumour such as proteins, the genetic material (genes, sections on the DNA) and the carriers of genetic information (RNA molecules) are examined using laboratory methods in order to be able to determine more reliably in future whether a tumour will reappear or not.

Title
International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones - Internationale Phase-3 Studie für Philadelphia-Chromosom-positive Akute lymphoblastische Leukämie
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Tobias Däbritz
EudraCT-number
2017-000705-20
Description
Approximately 3-5% of cases of ALL in children and adolescents are characterised by the presence of the Philadelphia chromosome (translocation t(9;22), molecular equivalent: BCR-ABL fusion). While historically the prognosis of affected children treated with conventional chemotherapy, supplemented if possible by allogeneic haematopoietic stem cell transplantation (HSCT), was extremely poor with cure rates of less than 50%, the systematic introduction of the tyrosine kinase inhibitor (TKI) imatinib, which was tested in a large European (EsPhALL) and several U.S. multicentre studies (COG), has led to the fact that more than half of patients can now be cured even without HSCT. However, the chemotherapy chosen in both consortia was highly intensive and accordingly associated with the occurrence of severe therapy toxicity including life-threatening infections; the use of high cumulative doses of anthracyclines and high-dose cytarabine as well as ifosfamide and etoposide also entails a high risk of severe long-term consequences. A reduction in these undesirable side effects while maintaining an acceptably low recurrence rate would represent a relevant advance in the treatment of affected children and adolescents.

Title
Eine internationale klinische Studie zur Diagnostik und Behandlung von Kindern, Jugendlichen und jungen Erwachsenen mit einem Ependymom
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Dr. med. Claudia Zinke
EudraCT-number
2013-002766-39
Description
Patients are stratified into different treatment arms based on age, tumour location and the result of the primary tumour resection. The goals differ depending on the stratum: Stratum 1: Does maintenance chemotherapy (16 weeks VEC-CDDP) after standard radiotherapy in patients = 12 months and complete tumour resection have a positive effect on tumour control as measured by progression-free survival (PFS)? Stratum 2: Does the addition of high-dose MTX to VEC chemotherapy improve tumour control in patients = 12 months with residual tumour after primary surgery? In patients = 12 months of age who still have an inoperable residual tumour after therapy, can a boost of 8 Gy directly following standard radiotherapy achieve local control of tumour growth, improve survival and maintain the patient's quality of life? Is boost radiotherapy safe for patients (toxicity)? Stratum 3: Does the addition of valproate to chemotherapy alone in children < 12 months have a potential benefit on progression-free survival (PFS)? (The aim of this treatment with valproate is to reduce the risk of chemotherapy resistance in order to maximise the intensity of treatment in very young children). All strata: Can accompanying molecular analyses within the BIOMECA study improve the further identification of prognostic markers and show the clinical relevance of these markers? Can central reference assessment of imaging improve the diagnosis of residual tumour disease and does this result in an improved rate of completely resected tumours compared to historical controls? Does the mandatory obtaining of a neurosurgical second opinion by the SIOP-Ependymoma II Neurosurgery Panel increase the proportion of patients with complete resection before the start of therapy?

Title
LBL 2018- Internationales Protokoll zur Behandlung von Kindern und Jugendlichen mit lymphoblastischen Lymphomen
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact
+49 351-4585035
Contact E-Mail-Address
Kik-dokuteam-hs65@ukdd.de
Examiner
Prof. Dr. med. Ralf Knöfler
EudraCT-number
2017-001691-39
Description
Primary research question Randomisation R1 (for all patients in the main study cohort): Can the cumulative incidence for recurrences with CNS involvement (CNS recurrence, pCICR) be reduced by an induction phase in which the three-week standard glucocorticoid therapy with prednisone (60mg/m²/d) plus tapering over 9 days is replaced by a 2-week dexamethasone treatment (10mg/m²/d)? Randomisation R2 (for high-risk patients in the main study cohort): For these patients, can the probability of event-free survival (pEFS) be improved by the intensified treatment arm (protocol Ib* and intensified protocol M) compared to the standard treatment arm (protocol Ib and protocol M)? Secondary research question the pEFS and the cumulative incidence of recurrence/CNS recurrence compared to the EURO-LB 02 clinical trial overall survival (OS), defined as the time from diagnosis to death (of any cause) or to the date of last contact with living patients compared to the EURO-LB 02 study treatment-related mortality in the randomised arms and in comparison to EURO-LB02 the profile of adverse events and serious adverse events in protocol-specific elements, in the randomisation arms, during follow-up and in comparison to EURO-LB02 the feasibility and results of risk stratification the identification of prognostic molecular markers for T-LBL the feasibility of evaluating minimal residual disease (MRD) in children and adolescents with LBL

Title
Heterogeneity, Evolution, and Resistance in Oncogenic Fusion Gene-Expressing Sarcomas Affecting Adolescents and Young Adults
Legal foundation
Berufsordnung
Contact
+49 351-4585541
Contact E-Mail-Address
master-dresden@nct-dresden.de
Examiner
Dr. med. Christoph Heining
Description
HEROES-AYA will use bone and soft-tissue sarcomas caused by chimeric fusion genes as paradigmatic diseases to study the development of heterogeneity in human cancers with clonally dominant, truncal genetic drivers in multiple dimensions and translate the insights gained into new strategies for diagnostics, prognostication, prediction of treatment response and resistance, and, most importantly, therapeutic targeting of heterogeneous and continuously evolving tumors. Tumors will be subjected to novel analysis methods that allow deconvolution at single-cell and spatial resolution to capture tumor heterogeneity and evolution at multiple levels. This will be complemented by in vitro and in vivo validation of potential new vulnerabilities and the development of innovative clinical trials for well-defined patient cohorts across age groups with the clear aim of improving clinical outcomes based on the discoveries made in this project. HEROES-AYA aims to recruit 220 patients to study the following groups of disease: Ewing sarcoma, Alveolar rhabdomyosarcoma, Desmoplastic small round cell tumor, Alveolar soft part sarcoma, Synovial sarcoma, Inflammatory myofibroblastic tumor, NTRK-rearranged sarcomas, BCOR-rearranged sarcomas, CIC-rearranged sarcomas, Solitary fibrous tumor, Myxoid liposarcoma, Epithelioid hemangioendothelioma.

Title
The Pancreatic Enzymes after Gastrectomy Trial
Phase
phase III
Legal foundation
Arzneimittelgesetz
Contact E-Mail-Address
studienzentrum-vtg@ukdd.de
Examiner
Prof. Dr. med. Daniel Stange
Registration
NCT06058442
EudraCT-number
2022-501944-14
Description
Can enzyme supplementation with every meal after gastrectomy lead to improved disease specific quality of life at 6 months after gastrectomy?

Title
Distress, Lebensqualität und Inanspruchnahme psychoonkologischer Unterstützungsangebote bei organtransplantierten und nicht transplantierten Patienten mit Hautkrebs
Legal foundation
Berufsordnung
Examiner
Dr. med. Ricarda Rauschenberg
Description
With this project, we want to investigate the psychological, physical and social stress associated with skin cancer and how great the need for psycho-oncological support is.

Title
Multiprofessionelle Versorgungsstruktur und Netzwerk zur Förderung von bedarfsorientierter, wohnortnaher Bewegungstherapie von onkologischen Patienten
Legal foundation
Berufsordnung
Contact
+49 0351-4583092
Contact E-Mail-Address
krebspraevention@ukdd.de
Examiner
Prof. Dr. med. Martin Bornhäuser
Registration
NCT06185777
Description
MOVE-ONKO would like to support people with cancer to get moving and to find an individually suitable sports and exercise therapy offer. To this end, we are implementing innovative and specific exercise advice and mediation as a new component in oncological care.

Title
Multizentrische Registerstudie zur Protonen-Radiotherapie bei mediastinalen Lymphomen
Legal foundation
Berufsordnung
Contact
+49 351-4582238
Contact E-Mail-Address
str.studien@uniklinikum-dresden.de
Examiner
Dr. med. Maximilian Rehm

Title
Körpermaterialstudie: NCT-MASTER Platform Molecularly aided stratification for tumor eradication research
Legal foundation
Berufsordnung
Contact
+49 351-5541
Contact E-Mail-Address
master-dresden@nct-dresden.de
Examiner
Prof. Dr. med. Hanno Glimm
Description
.“Precision oncology” describes the ability to predict which patients will likely respond to specific cancer therapies based on comprehensive, high-resolution molecular diagnostics as well as the functional understanding of individual tumors. Such stratification of patients can be achieved, e.g., through next-generation sequencing of tumor DNA and RNA, revealing genomic alterations that have immediate clinical implications. DKFZ/NCT/DKTK MASTER provides a complete workflow for selection and consenting of patients, tissue processing, whole-exome/genome and RNA sequencing, bioinformatic analysis, and molecularly guided clinical decision making by molecular tumor boards, which are held three times a week and include members with expertise in clinical oncology, pathology, molecular biology, bioinformatics, and medical genetics and counseling. Since many molecular alterations identified in human cancers have unknown functional consequences and can therefore not directly be interpreted regarding their suitability as therapeutic targets, separating “driver” mutations from biologically neutral “passenger” alterations is critical for translating genetic information into the clinic. Furthermore, the therapeutic value of known oncogenic mutations may vary depending on tissue context. To address these challenges, we investigate the functional role of genetic alterations predicted to be damaging in appropriate experimental systems, followed by the analysis of phenotypic consequences. The goal of these studies is to establish a versatile platform for rapid “functionalization” of individual molecular profiles and develop a continuously evolving, “learning” system to support treatment decisions at NCT.