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Phase II trial in inoperable œsophageal cancer evaluating the feasibility of the combination of definitive chemoradiation with the immune checkpoint blockers Nivolumab +/- Ipilimumab (CRUCIAL)

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 17-Jan-2019
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
Markus Moehler (Study Coordinator) , Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center, Mainz
Laila Ben Salama (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Maike Collienne (Medical Fellow) , EORTC Headquarters, Brussels
Pierre-Edouard Dollet (Project Manager) , EORTC Headquarters, Brussels
Nathalie Elaut (Data Manager) , EORTC Headquarters, Brussels
Anne Giraut (Clinical Scientist) , EORTC Headquarters, Brussels
Nawal Khaldi (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Murielle Mauer (Statistician) , EORTC Headquarters, Brussels
Marie Morfouace (TR Scientist) , 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
Zineb Wadid (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer Esophageal
Participating groups EORTC Gastrointestinal Tract Cancer Group
EORTC Radiation Oncology Group
Recruiting centers Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France)
CHU de Limoges - Hopital Dupuytren (Limoges, France)
Centre Hospitalier Prive Saint-Gregoire (Saint-Gregoire, France)
Centre de Radiotherapie Pierre Curie (Beuvry, France)
Gustave Roussy (Villejuif, 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
NCT number NCT03437200
EudraCT 2018-000053-53
Financial Support Educational Grant