EORTC-2120-HNCG

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Radiotherapy plus xevinapant or placebo in older patients with locally advanced head and neck squamous cell carcinoma: a randomized phase II study

Study documentation

Trial Status	Recruiting
Dates	Date of activation: 15-Nov-2023
Data management at EORTC	Yes
Design	Phase 2 Randomized blind
Targeted Sample size	EORTC Groups: 230 - All Groups: 230
Treatment	Radiotherapy, Drug Xevinapant, Placebo
Study Staff	Sjoukje Oosting (Study Coordinator) , University Medical Center Groningen, Groningen Pierluigi Bonomo (Study Co-Coordinator) , Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi, Firenze Enrico Clementel (Imaging Officer) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Laura De Meulemeester (Study RTSM designer) , EORTC Headquarters, Brussels Benedicte Demeulder (Project Manager) , EORTC Headquarters, Brussels Carolina Fernandes (Unblinded COM) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Beatrice Fournier (Unblinded Clinical Scientist) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels Fanny Grillet (TR Scientist) , EORTC Headquarters, Brussels Selin Gundogan (Unblinded COM) , EORTC Headquarters, Brussels Lore Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Ana Joaquim (Clinical Research Physician) , EORTC Headquarters, Brussels Alexandra Jouret (Project Manager) , EORTC Headquarters, Brussels Murielle Mauer (Unblinded statistician) , EORTC Headquarters, Brussels Madeline Pe (QoL Specialist) , EORTC Headquarters, Brussels Valentina Pomella (Clinical Operations Manager) , EORTC Headquarters, Brussels Daniel Portik (Medical Fellow) , EORTC Headquarters, Brussels Miguel Remis (Lead CRA) , EORTC Headquarters, Brussels Gilles Sarlet (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Luiza Souza (QART Manager) , EORTC Headquarters, Brussels Disnelly Torres (Study Designer) , EORTC Headquarters, Brussels Konstantina Tsechilidou (Data Manager) , EORTC Headquarters, Brussels Denisse Tubay (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Yuliya Vostrikova (Clinical Data Expert) , EORTC Headquarters, Brussels Leen Wijnen (Study Designer) , EORTC Headquarters, Brussels
Type of cancer	Head and Neck
Participating groups	EORTC Head and Neck Cancer Group
Recruiting centers	APHP Sorbonne Univ - Hopital Tenon (PARIS, France) Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands) Centre Oscar Lambret (LILLE CEDEX, France) Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany) Cliniques Universitaires Saint-Luc (Brussels, Belgium) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) IRCCS--Ospedale Bellaria-Bologna (Bologna, Italy) Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France) Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) The Institute Of Oncology (Ljubljana, Slovenia) Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany) Universitair Ziekenhuis Gent (Gent, Belgium) University Medical Center Groningen (Groningen, Netherlands)
Centers to be activated	APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) AUSL Bologna - Ospedale Bellaria (Bologna, Italy) Academisch Ziekenhuis Maastricht (Maastricht, Netherlands) Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom) Helse Bergen HF -Haukeland Hospital - Univ. Hosp (Bergen, Norway) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Istituto Clinico Humanitas (Rozzano, Milano, Italy) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) SLRON - St. Luke'S Hospital Rathgar (Dublin, Ireland) Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) Universitaetsklinikum - Essen (Essen, Germany) University Hospital Galway (Galway, Ireland) University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom)
Protocol summary	http://clinicaltrials.gov/study/NCT05724602
NCT number	NCT05724602
Financial Support	Educational Grant