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 Davide Passariello (Clinical Operations 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 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