Study

EORTC-2120-HNCG

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

Study documentation Back to result

Trial Status

Closed to Patient Entry

Dates

Date of activation: 15-Nov-2023
Date Step1 close: 02-Jul-2024

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
  • Alexandra Jouret (Project Manager), EORTC Headquarters, Brussels
  • Ana Joaquim (Clinical Research Physician), EORTC Headquarters, Brussels
  • Anne-Sophie Govaerts (Clinical Scientist), EORTC Headquarters, Brussels
  • Jedelyn Cabrieto (Statistician), EORTC Headquarters, Brussels
  • Corneel Coens (Statistician), EORTC Headquarters, Brussels
  • Catherine Fortpied (Statistician), EORTC Headquarters, Brussels
  • Lieve Dirix (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Konstantina Tsechilidou (Data Manager), EORTC Headquarters, Brussels
  • Leen Wijnen (Study Designer), EORTC Headquarters, Brussels
  • Yuliya Vostrikova (Clinical Data Expert), EORTC Headquarters, Brussels
  • Denisse Tubay (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Gilles Sarlet (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Miguel Remis (Lead CRA), EORTC Headquarters, Brussels
  • Enrico Clementel (Imaging Officer), EORTC Headquarters, Brussels
  • Daniel Portik (Medical Fellow), EORTC Headquarters, Brussels
  • Madeline Pe (QoL Specialist), EORTC Headquarters, Brussels
  • Beatrice Fournier (Unblinded Clinical Scientist), EORTC Headquarters, Brussels
  • Carolina Fernandes (Unblinded COM), EORTC Headquarters, Brussels
  • Murielle Mauer (Unblinded statistician), EORTC Headquarters, Brussels
  • Coreen Corning (RTQA Officer), EORTC Headquarters, Brussels
  • Luiza Souza (RTQA Officer), 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)
  • AZORG (previous Onze Lieve Vrouw ZK) (Aalst, Belgium)
  • Amsterdam UMC stichting - 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)
  • 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)

Protocol summary

http://clinicaltrials.gov/study/NCT05724602

NCT number

NCT05724602