Study

EORTC-1740-HNCG-LA-OSCC

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 Back to result

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
  • Lisa Licitra (Study Co-Coordinator), IRCCS - Fondazione Istituto Nazionale dei Tumori, Milano
  • Christian Alfano (Project Manager), EORTC Headquarters, Brussels
  • Anne-Sophie Govaerts (Clinical Scientist), EORTC Headquarters, Brussels
  • Ellen Peeters (Senior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Yuliya Vostrikova (Data Manager), EORTC Headquarters, Brussels
  • Denisse Tubay (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Denisse Tubay (Junior PVM), EORTC Headquarters, Brussels
  • Gilles Sarlet (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Zineb Wadid (Lead CRA), EORTC Headquarters, Brussels
  • Jedelyn Cabrieto (Senior Statistician), EORTC Headquarters, Brussels
  • Coreen Corning (RTQA Officer), 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)
  • 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)
  • ZAS Augustinus (previous GZA) (Wilrijk, Belgium)

Protocol summary

http://clinicaltrials.gov/study/NCT03410615

NCT number

NCT03410615

EudraCT

2019-000308-13