Study

EORTC-1219-ROG-HNCG

A blind randomized multicenter study of accelerated fractionated chemo-radiotherapy with or without the hypoxic radiosensitizer nimorazole (Nimoral), using a 15 gene signature for hypoxia in the treatment of squamous cell carcinoma of the head and neck

Study documentation Back to result

Trial Status

All trial activities ended

Dates

Date of activation: 27-May-2014
Date Step1 close: 13-Feb-2018
Date Step2 close: 13-Feb-2018

Data management at EORTC

Yes

Design

Phase 3
Randomized blind

Targeted Sample size

EORTC Groups: 640 - All Groups: 640

Treatment

Radiotherapy, Drug
Cisplatin, Nimorazole, Blind trial medication-1219

Type of cancer

Head and Neck

Participating groups

EORTC Head and Neck Cancer Group
EORTC Radiation Oncology Group
Trans-Tasman Radiation Oncology Group Inc
Danish Head & Neck Cancer Group

Recruiting centers

Amsterdam UMC stichting - locatie VUMC (Amsterdam, Netherlands)
CHU de Tours - Hopital Bretonneau (Tours, France)
CLCC - Jean Perrin (Clermont-Ferrand, France)
Calvary Mater Newcastle (Waratah, Australia)
Centre Georges-Francois-Leclerc (Dijon, France)
Centre Oscar Lambret (Lille, France)
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Greater Poland Cancer Centre (Poznan, Poland)
Gustave Roussy (Villejuif, France)
Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
ICON Cancer Center -Gold Coast University Hospital (Southport QLD, Australia)
Institut Jules Bordet (Anderlecht, Belgium)
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Royal Brisbane And Women's Hospital (Herston - Brisbane, Australia)
Royal North Shore Hospital (St Leonards, Australia)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinik Dusseldorf (Duesseldorf, Germany)
Universitaetsklinikum Wuerzburg (Wuerzburg, Germany)
University Health Network / Princess Margaret Cancer Center (Toronto, Canada)
Wroclaw Comprehensive Cancer Centre (Dolnoslaskie Centrum Onkologi) (Wroclaw, Poland)

Protocol summary

http://clinicaltrials.gov/study/NCT01880359

NCT number

NCT01880359

EudraCT

2013-002441-12