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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)

Study documentation

Trial Status Recruiting
Dates Date of activation: 31-Oct-2019
Data management at EORTC No
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 50 - All Groups: 180
Treatment Radiotherapy, Drug
Study Staff Jean-Pascal Machiels (Study Coordinator) , Cliniques Universitaires Saint-Luc, Brussels
Coreen Corning (QART Manager) coreen.corning (at), EORTC Headquarters, Brussels
Laura De Meulemeester (Clinical Operations Manager) laura.demeulemeester (at), EORTC Headquarters, Brussels
Catherine Fortpied (Statistician) catherine.fortpied (at), EORTC Headquarters, Brussels
Anne-Sophie Govaerts (Clinical Scientist) anne-sophie.govaerts (at), EORTC Headquarters, Brussels
Lisa Licitra (Study Co-Coordinator) , IRCCS - Istituto Nazionale dei Tumori, Milano
Livia Meirsman (Project Manager) livia.meirsman (at), EORTC Headquarters, Brussels
Jean-Paul Nzanzu (Lead CRA) jean-paul.nzanzu (at), EORTC Headquarters, Brussels
Tiana Raveloarivahy (Data Manager) tiana.raveloarivahy (at), EORTC Headquarters, Brussels
Gilles Sarlet (Regulatory Affairs Manager) gilles.sarlet (at), EORTC Headquarters, Brussels
Sophie Schrevens (Clinical Research Associate/Monitor) sophie.schrevens (at), EORTC Headquarters, Brussels
Lucia Senna (Clinical Operations Assistant) lucia.senna (at), EORTC Headquarters, Brussels
Ionela Stanciu (Junior Clinical Operations Manager) ionela.stanciu (at), EORTC Headquarters, Brussels
Bette Stofs (Pharmacovigilance Manager) bette.stofs (at), EORTC Headquarters, Brussels
Maureen Vanlancker (Clinical Research Physician) maureen.vanlancker (at), 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)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Universitair Ziekenhuis Gent (Gent, Belgium)
Centers to be activated IRCCS - Istituto Nazionale dei Tumori (Milano, Italy)
Protocol summary
NCT number NCT03410615
EudraCT 2019-000308-13