Study

EORTC-2014-HNCG

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

Study documentation Back to result

Trial Status

Regulatory in Process

Dates

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
  • Jedelyn Cabrieto (Statistician), EORTC Headquarters, Brussels
  • Enrico Clementel (QART Manager), EORTC Headquarters, Brussels
  • Corneel Coens (Statistician), EORTC Headquarters, Brussels
  • Coreen Corning (QART Manager), EORTC Headquarters, Brussels
  • Lieve Dirix (Senior Clinical Operations 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
  • Selin Gundogan (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Ana Joaquim (Clinical Research Physician), EORTC Headquarters, Brussels
  • Jean-Pascal Machiels (Study Co-Coordinator), Cliniques Universitaires Saint-Luc, Brussels
  • Arnaud Poncin (Data Manager), EORTC Headquarters, Brussels
  • Miguel Remis (Lead CRA), EORTC Headquarters, Brussels
  • Lucy Sepulveda (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
  • Stefanos Soraruff (Clinical Operations Assistant), EORTC Headquarters, Brussels
  • Luiza Souza (QART Manager), EORTC Headquarters, Brussels
  • Ionela Stanciu (Clinical Operations 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

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)
  • 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)
  • Inselspital (Bern, Switzerland)
  • Istituto Clinico Humanitas (Rozzano, Milano, Italy)
  • Kantonsspital Aarau (Aarau, Switzerland)
  • Kantonsspital Graubuenden (Chur, Switzerland)
  • Kantonsspital Winterthur (Winterthur, Switzerland)
  • Luzerner Kantonsspital (Luzern, Switzerland)
  • Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland)
  • Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
  • UniversitaetsSpital Zurich (Zurich, Switzerland)
  • VITAZ- Oncology (Sint Niklaas, Belgium)
  • ZAS Augustinus (previous GZA) (Wilrijk, Belgium)

Protocol summary

http://clinicaltrials.gov/study/NCT05815927

NCT number

NCT05815927