Clinical Trial Details

EORTC-1420-HNCG-ROG

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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

Trial Status Recruiting
Dates Date of activation: 27-Nov-2017
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
Jose Casas (TR Scientist) , EORTC Headquarters, Brussels
Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels
Coreen Corning (QART Manager) , EORTC Headquarters, Brussels
Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels
Amaya Gonzalez (Clinical Research Associate/Monitor) , 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
Jeremy Leys (Clinical Operations Manager) , EORTC Headquarters, Brussels
Davide Passariello (Clinical Operations Manager) , EORTC Headquarters, Brussels
Davide Passariello (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
Egle Venslovaite (Project 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 (Junior RAM) , 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 Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar (Muenchen, Germany)
Klinikum St Georg - Standort Eutritzsch (Leipzig, Germany)
Klinikum St Georg - Standort Eutritzsch (Leipzig, Germany)
Martin Luther Universitaet - Universitätsklinikum Halle (Saale) (Halle (Saale), 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 Greifswald der Ernst Morizt Arndt Univ. Greifswald AoR (Greifswald, Germany)
Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
Universitaetsklinikum Jena (Jena, Germany)
Universitaetsklinikum Jena (Jena, Germany)
Universitaetsklinikum Koeln (Koeln, Germany)
Universitaetsklinikum Koeln (Koeln, Germany)
Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany)
Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany)
Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
Universitaetsklinikum Ulm-Michelsberg-HNO (Ulm, 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)
Centers to be activated Universitaetklinikum Giessen und Marburg GmbH - Campus Giessen (Giessen, Germany)
Universitaetklinikum Giessen und Marburg GmbH - Campus Giessen (Giessen, Germany)
Protocol summary http://clinicaltrials.gov/study/NCT02984410
NCT number NCT02984410
Financial Support EORTC HQ
FOCA
Georges Dreyfus Foundation
SAKK
GORTEC