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

Study documentation

Trial Status Recruiting
Dates Date of activation: 18-Oct-2018
Data management at EORTC Yes
Design Phase 2
Not randomized / N.A.
Targeted Sample size EORTC Groups: 66 - All Groups: 66
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
Marianna Del Sole (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels
Giovanna Farro (Clinical Scientist) , EORTC Headquarters, Brussels
Alessandro Gugino (Project 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
Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Khadija Rhioui (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Maira Seini (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Yuko Takahashi (Medical Fellow) , EORTC Headquarters, Brussels
Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Sofie Verschueren (Clinical Operations Manager) , EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer Colorectal
Participating groups EORTC Gastrointestinal Tract Cancer Group
Recruiting centers Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
Innsbruck Universitaetsklinik (Innsbruck, Austria)
Inselspital (Bern, Switzerland)
Institut Bergonie (Bordeaux, France)
Karolinska Institutet - Danderyds Hospital (Stockholm, Sweden)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinikum Leipzig UCCL-Krebszentrum (Leipzig, Germany)
Centers to be activated Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik (Magdeburg, Germany)
Universitaetsklinikum Carl Gustav Carus (Dresden, Germany)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
Protocol summary http://clinicaltrials.gov/ct/show/NCT03101475
NCT number NCT03101475
EudraCT 2017-001375-22
Financial Support Educational Grant