EORTC-2014-HNCG

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Pembrolizumab and Radiotherapy for OLigometastatic squamous cell carcinoma of the head and Neck : a randomized phase III study

Study documentation

Trial Status	Regulatory in Process
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	EORTC Groups: 200 - All Groups: 200
Treatment	Radiotherapy, Drug Pembrolizumab
Study Staff	Panagiotis Balermpas (Study Coordinator) , UniversitaetsSpital Zurich, Zurich Ahu Alanya (QoL Specialist) , EORTC Headquarters, Brussels Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Irina Ghislain (QoL Specialist) , EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels Fanny Grillet (TR Manager) , EORTC Headquarters, Brussels Ana Joaquim (Clinical Research Physician) , EORTC Headquarters, Brussels Jean-Pascal Machiels (Study Co-Coordinator) , Cliniques Universitaires Saint-Luc, Brussels Valentina Pomella (Clinical Operations Manager) , EORTC Headquarters, Brussels Arnaud Poncin (Data Manager) , EORTC Headquarters, Brussels Miguel Remis (Lead CRA) , EORTC Headquarters, Brussels Lucy Sepulveda (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Luiza Souza (QART Manager) , EORTC Headquarters, Brussels Jelle Stans (Junior RAM) , EORTC Headquarters, Brussels Denisse Tubay (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Egle Venslovaite (Project Manager) , EORTC Headquarters, Brussels Yuliya Vostrikova (Clinical Data Expert) , EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer	Head and Neck
Participating groups	EORTC Head and Neck Cancer Group Schweizerisches Arbeitsgemeinschaft Klin. Krebsforschung
Centers to be activated	AUSL - Ospedale Infermi (Faenza, Italy) AUSL -Ospedale Umberto I (Lugo, Italy) AUSL Della Romagna -Ospedale Santa Maria delle Croci (Ravenna, Italy) AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) Azienda Sanitaria Locale Napoli 1 Centro (Napoli, Italy) Azienda ospedaliero Univ Policlinico Umberto I (Roma, Italy) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) Cliniques Universitaires Saint-Luc (Brussels, Belgium) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario Ramon y Cajal (Madrid, Spain) Hospital Universitario San Carlos (Madrid, Spain) Hospital Universitario de Gran Canaria Doctor Negrin (Las Palmas de Gran Canaria, 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) IRCCS--Ospedale Bellaria-Bologna (Bologna, Italy) Istituto Clinico Humanitas (Rozzano, Milano, Italy) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) VITAZ- Oncology (Sint Niklaas, Belgium)
Protocol summary	http://clinicaltrials.gov/study/NCT05815927
NCT number	NCT05815927
Financial Support	MSD AG Switzerland Fondation Contre le Cancer Asociaon Espanola contra el Cancer EORTC Cancer Research Fund