Clinical Trial Details
EORTC-1740-HNCG
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Randomized Phase II study of Cisplatin plus Radiotherapy versus Durvalumab plus Radiotherapy followed by Adjuvant Durvalumab versus Durvalumab plus Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)
| Trial Status | Closed to Patient Entry |
|---|---|
| Dates |
Date of activation: 31-Oct-2019 Date Step1 close: 16-Nov-2022 |
| Data management at EORTC | No |
| Design |
Phase 2 Randomized open label |
| Targeted Sample size | EORTC Groups: 50 - All Groups: 180 |
| Treatment |
Radiotherapy, Drug Cisplatin, Durvalumab |
| Study Staff |
Jean-Pascal Machiels (Study Coordinator) , Cliniques Universitaires Saint-Luc, Brussels Christian Alfano (Project Manager) , EORTC Headquarters, Brussels Adrien Augustin (Clinical Operations Manager) , EORTC Headquarters, Brussels Jessica Berger (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Ilse Coppens (Clinical Operations Assistant) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels Lisa Licitra (Study Co-Coordinator) , IRCCS - Fondazione Istituto Nazionale dei Tumori, Milano Gilles Sarlet (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Denisse Tubay (Junior PVM) , EORTC Headquarters, Brussels Denisse Tubay (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Yuliya Vostrikova (Data Manager) , EORTC Headquarters, Brussels Zineb Wadid (Lead CRA) , EORTC Headquarters, Brussels |
| Type of cancer | Head and Neck |
| Participating groups |
EORTC Head and Neck Cancer Group Canadian Cancer Trials Group |
| Recruiting centers |
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Complejo Hospitalario de Navarra (Pamplona, Spain) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Hospital Clinico Universitario De Valencia (Valencia, Spain) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario Ramon y Cajal (Madrid, Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Universitair Ziekenhuis Gent (Gent, Belgium) |
| Protocol summary | http://clinicaltrials.gov/study/NCT03410615 |
| NCT number | NCT03410615 |
| EudraCT | 2019-000308-13 |
| Financial Support | Educational Grant |
