Study

EORTC-1420-HNCG-ROG

Phase III study assessing the “best of” radiotherapy compared to the “best of” surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0-N1 oropharyngeal, supraglottic carcinoma and with T1, N0 hypopharyngeal carcinoma

Study documentation Back to result

Trial Status

Closed to Patient Entry

Dates

Date of activation: 27-Nov-2017
Date Step1 close: 29-May-2024
Date Step2 close: 29-May-2024

Data management at EORTC

Yes

Design

Phase 3
Randomized open label

Targeted Sample size

All Groups: 170

Treatment

Radiotherapy, Surgery

Study Staff

  • Christian Simon (Study Coordinator), Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne
  • Jessica Berger (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Enrico Clementel (QART Manager), 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
  • Anne-Sophie Govaerts (Clinical Scientist), EORTC Headquarters, Brussels
  • Vincent Gregoire (Study Co-Coordinator), Centre Leon Berard, Lyon
  • Piet Gutscoven (Data Manager), EORTC Headquarters, Brussels
  • Ana Joaquim (Clinical Research Physician), EORTC Headquarters, Brussels
  • Davide Passariello (Clinical Operations Manager, Project Manager), EORTC Headquarters, Brussels
  • Eliza Starczewska (Regulatory Affairs Administrator), 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
  • Zineb Wadid (Lead CRA), EORTC Headquarters, Brussels
  • Leen Wijnen (Data Manager), EORTC Headquarters, Brussels
  • Xiao Mang Zhou (Regulatory Affairs Manager), EORTC Headquarters, Brussels

Type of cancer

  • Head and Neck

Participating groups

  • EORTC Head and Neck Cancer Group
  • EORTC Radiation Oncology Group
  • Groupe d'Oncologie et Radiotherapie Tete et Cou
  • National Cancer Research Institute - Head & Neck Cancer Grp
  • Interdisziplinaere AG Kopf-Hals-Tumoren

Recruiting centers

  • Aintree University Hospital NHS Trust (Liverpool, United Kingdom)
  • Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
  • CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
  • Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
  • Cardiff and Vale University Health Board - University Hospital of Wales (Cardiff, United Kingdom)
  • Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
  • Cliniques Universitaires Saint-Luc (Brussels, Belgium)
  • Greater Poland Cancer Centre (Poznan, Poland)
  • Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
  • Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg Cedex 1, France)
  • Hospital Universitario Central De Asturias (Oviedo, Spain)
  • Hospital Universitario Donostia (Donostia-Gipuzkoa, Spain)
  • Hospital Universitario Ramon y Cajal (Madrid, Spain)
  • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital (Cottingham, United Kingdom)
  • Imperial College Healthcare NHS Trust - Charing Cross Hospital (London, United Kingdom)
  • Inselspital (Bern, Switzerland)
  • Institut Jules Bordet (Anderlecht, Belgium)
  • Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France)
  • Istituto Clinico Humanitas (Rozzano, Milano, Italy)
  • Istituto Europeo di Oncologia (Milano, Italy)
  • Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar (Muenchen, Germany)
  • Klinikum St Georg - Standort Eutritzsch (Leipzig, Germany)
  • Martin Luther Universitaet - Universitätsklinikum Halle (Saale) (Halle (Saale), Germany)
  • The James Cook University Hospital (Middlesbrough, United Kingdom)
  • U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
  • UniversitaetsSpital Zurich - Klinik fur Ohren, Hals und Gesichtschirurgie (Zurich, Switzerland)
  • Universitaetsklinikum Greifswald der Ernst Morizt Arndt Univ. Greifswald AoR (Greifswald, Germany)
  • Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
  • Universitaetsklinikum Jena (Jena, Germany)
  • Universitaetsklinikum Koeln (Koeln, Germany)
  • Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany)
  • Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
  • Universitaetsklinikum Ulm-Michelsberg-HNO (Ulm, Germany)
  • Universitaetsspital Basel (Basel, Switzerland)
  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom)

Protocol summary

http://clinicaltrials.gov/study/NCT02984410

NCT number

NCT02984410