Clinical Trial Details
EORTC-1219-ROG-HNCG
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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
| 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 |
| Study Staff |
Vincent Gregoire (Study Coordinator) , Centre Leon Berard, Lyon Jens Overgaard (Study Coordinator) , Region Midtjylland - Aarhus University Hospital-Skejby, Aarhus Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels |
| 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 - 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 CEDEX, France) Centre Oscar Lambret (LILLE CEDEX, France) Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Greater Poland Cancer Centre (Poznan, Poland) Gustave Roussy (VILLEJUIF CEDEX, 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 - Oci / Princess Margaret Hospital (Toronto, Canada) University Health Network - Oci / Princess Margaret Hospital (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 |
| Financial Support | Educational Grant |
