Clinical Trial Details
EORTC-1560-GITCG
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Phase II of immunotherapy plus local tumour ablation (RFA or stereotactic radiotherapy) in patients with colorectal cancer liver metastases
| Trial Status | All trial activities ended |
|---|---|
| Dates |
Date of activation: 18-Oct-2018 Date Step1 close: 03-Mar-2021 |
| Data management at EORTC | Yes |
| Design |
Phase 2 Not randomized / N.A. |
| Targeted Sample size | EORTC Groups: 70 - All Groups: 70 |
| Treatment |
Radiotherapy, Drug Durvalumab, Tremelimumab |
| Study Staff |
Theo Ruers (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam Jenny Seligmann (Study Coordinator) , Leeds Teaching Hospitals NHS Trust - St. James's University Hospital, Leeds Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Peter De Burghgraeve (Data Manager) , EORTC Headquarters, Brussels Marie-Ange Lentz (Data Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Murielle Mauer (Statistician) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Maira Seini (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Sofie Verschueren (Clinical Operations Manager) , EORTC Headquarters, Brussels |
| Type of cancer | Colorectal |
| Participating groups | EORTC Gastrointestinal Tract Cancer Group |
| Recruiting centers |
Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland) Inselspital (Bern, Switzerland) Institut Bergonie (Bordeaux, France) Karolinska Institutet - Danderyd Hospital (Huddinge, Sweden) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) UniversitaetsSpital Zurich (Zurich, Switzerland) Universitaetsklinikum Carl Gustav Carus (TUD) (Dresden, Germany) Universitaetsklinikum Leipzig UCCL-Krebszentrum (Leipzig, Germany) |
| Centers to be activated | Universitaetsklinikum Wien - AKH unikliniken (Vienna, Austria) |
| Protocol summary | http://clinicaltrials.gov/study/NCT03101475 |
| NCT number | NCT03101475 |
| EudraCT | 2017-001375-22 |
| Financial Support | Educational Grant |
