Clinical Trial Details
EORTC-1714-GITCG-ROG
Back to Clinical Trials Database
Phase II trial in inoperable œsophageal cancer evaluating the feasibility of the combination of definitive chemoradiation with the immune checkpoint blockers Nivolumab +/- Ipilimumab (CRUCIAL)
Trial Status | Closed to Patient Entry |
---|---|
Dates |
Date of activation: 17-Jan-2019 Date Step1 close: 27-Nov-2020 |
Data management at EORTC | Yes |
Design |
Phase 2 Randomized open label |
Targeted Sample size | EORTC Groups: 130 - All Groups: 130 |
Treatment |
Radiotherapy, Drug Ipilimumab, Nivolumab |
Study Staff |
Eric Deutsch (Study Coordinator) , Gustave Roussy, VILLEJUIF CEDEX Markus Moehler (Study Coordinator) , Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center, Mainz Nathalie Elaut (Data Manager) , EORTC Headquarters, Brussels Anne Giraut (Clinical Scientist) , EORTC Headquarters, Brussels Murielle Mauer (Statistician) , EORTC Headquarters, Brussels Eliza Starczewska (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Sofie Verschueren (Clinical Operations Manager) , EORTC Headquarters, Brussels |
Type of cancer | Esophageal |
Participating groups |
EORTC Gastrointestinal Tract Cancer Group EORTC Radiation Oncology Group |
Recruiting centers |
APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France) Centre Hospitalier Prive Saint-Gregoire (Saint-Gregoire, France) Centre de Radiotherapie Pierre Curie (Beuvry, France) Gustave Roussy (VILLEJUIF CEDEX, France) Hospital Del Mar (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital Universitario de Gran Canaria Doctor Negrin (Las Palmas de Gran Canaria, Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) |
Protocol summary | http://clinicaltrials.gov/study/NCT03437200 |
NCT number | NCT03437200 |
EudraCT | 2018-000053-53 |
Financial Support | Educational Grant |