SIOPE ATRT01

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.

{ "short_title": "SIOPE ATRT01", "data_mode": "900", "data_mode_number": "000002458", "official_title": "Internationale, prospektive \u201cUmbrella\u201d-Studie f\u00fcr 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. ", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": null, "therapielinie_value": "first", "ctgov_number": null, "eudract_number": "2018-003325-29", "general_contact_email": "Kik-dokuteam-hs65@ukdd.de", "general_contact_phone": "+49 351-4585035", "hauptpruefer_dd_name": "Dr. med. Claudia Zinke", "description_laie_de": "Prospektive, \u201copen label\u201d, multizentrische, internationale \u201cUmbrella\u201d Studie incl. einer randomisierten Phase III-Studie zur Frage der Nichtunterlegenheit von 3 Kursen Hochdosis-Chemotherapie verglichen mit fokaler Radiotherapie plus Standard-Chemotherapie in der Konsolidierung nach einer konventionellen Induktionschemotherapie f\u00fcr Kinder mit einem ATRT im Alter von 12 - 35 Monaten zum Zeitpunkt der Bestrahlung.", "description_laie_en": "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.", "description_expert_de": null, "description_expert_en": "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.\r\n\r\nRandomised arm Part A\r\nTo 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.\r\n\r\nPart B (non-randomised)\r\nTo 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.\r\n\r\nPart C (non-randomised)\r\nEvaluation 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.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 14, "sub_cat_id": 62 }