Clinical Trial Details

EORTC-1714-GITCG-ROG

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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
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