Hi-STEP1

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.

{ "short_title": "Hi-STEP1", "data_mode": "900", "data_mode_number": "000002242", "official_title": "Pr\u00e4diktion des Ansprechens auf Hypertherme Intraperitoneale Chemotherapie in gastrointestinalen Krebserkrankungen", "accrual_state": "running", "therapeutic_value": "nonTherapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": null, "eudract_number": null, "general_contact_email": "studienzentrum-vtg@ukdd.de", "general_contact_phone": null, "hauptpruefer_dd_name": "Prof. Dr. med. Daniel Stange", "description_laie_de": "Eine synchrone peritoneale Metastasierung beim fortgeschrittenen Magen- oder Kolonkarzinom stellt trotz moderner Therapieverfahren immer noch eine verheerende Diagnose f\u00fcr die betroffenen Patienten dar. Denn nicht nur die Lebensqualit\u00e4t ist unter anderem durch Passagest\u00f6rungen und Ileus deutlich reduziert, auch die Lebenserwartung ist drastisch eingeschr\u00e4nkt. Durch eine moderne systemische Chemotherapie kann das Gesamt\u00fcberleben zwar erh\u00f6ht werden, eine Heilung ist jedoch nicht m\u00f6glich.\r\nIm Rahmen einer multimodalen Therapie hat sich bei gering ausgepr\u00e4gter PC eine Behandlungskombination aus vollst\u00e4ndiger chirurgischer Resektion und Perfusion mittels hyperthermer intraperitonealer Chemotherapie (HIPEC) etabliert. Es konnte gezeigt werden, dass so eine deutliche Steigerung des Gesamt\u00fcberlebens erreicht werden kann. Jedoch sind PC-Rezidivraten mit bis zu 80% immer noch sehr hoch. Zudem mangelt es diesem Behandlungsverfahren trotz weltweitem Einsatz seit \u00fcber 30 Jahren an Standards sowie an patientengerichteter Individualisierbarkeit. So sind allein f\u00fcr die PC bei Kolonkarzinom international \u00fcber 60 verschiedene HIPEC-Schemata in Verwendung, welche sich bislang haupts\u00e4chlich auf Beobachtungsstudien oder prospektiven Single-Arm Studien berufen.\r\nDaher bietet die PC ein klinisches Setting zur pr\u00e4klinischen Medikamententestung z.B. mittels Organoidmodellen, um eine auf jeden einzelnen Patienten zugeschnittene, optimale Behandlung in Zukunft zu erm\u00f6glichen. Die vorliegende explorative Pilotstudie zielt auf die Etablierung von Organoidkulturen aus Tumormaterial f\u00fcr die pr\u00e4klinische Testung von HIPEC-Schemata in Form von Mono- und Kombinationstherapien, um so den pr\u00e4diktiven Wert des Organoidmodells hinsichtlich der Effektivit\u00e4t der HIPEC-Prozedur zu untersuchen.Parallel erfolgen molekulargenetische Untersuchungen an den Organoidkulturen, um Resistenz gegen\u00fcber der systemischen neoadjuvanten Therapie zu untersuchen.", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "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.\r\nAs 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.\r\nThus, 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.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 2, "sub_cat_id": 6 }

Settings