Study

EORTC-1714-GITCG-ROG-CRUCIAL

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 Back to result

Trial Status

LT-FU ongoing

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
  • Markus Moehler (Study Coordinator), Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center, Mainz
  • Sofie Verschueren (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Nathalie Elaut (Data Manager), EORTC Headquarters, Brussels
  • Eliza Starczewska (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
  • Murielle Mauer (Lead Statistician), 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, 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)

Centers to be activated

  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany)
  • Institut Public De Cancerologie Strauss Europe-Strauss Institute (Strasbourg, France)
  • Knappschaftskrankenhaus Bottrop (Bottrop, Germany)
  • Regiomed Kliniken Coburg (Coburg, Germany)
  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany)

Protocol summary

http://clinicaltrials.gov/study/NCT03437200

NCT number

NCT03437200

EudraCT

2018-000053-53