Clinical Trial Details

EORTC-1635-BTG

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IDH mutated 1p/19q intact lower grade glioma following resection: Wait Or Treat? IWOT - A phase III study

Study documentation

Trial Status Recruiting
Dates Date of activation: 12-Mar-2020
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 450 - All Groups: 450
Treatment Radiotherapy, Drug
Temozolomide
Study Staff Joerg-Christian Tonn (Study Coordinator) , Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern, Muenchen
Martin J. van den Bent (Study Coordinator) , Erasmus MC , Rotterdam
Mihaela Balanescu (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Isabelle Blangenois (Data Manager) , EORTC Headquarters, Brussels
Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels
Coreen Corning (QART Manager) , EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels
Alessandro Gugino (Project Manager) , EORTC Headquarters, Brussels
Julie Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Hafida Lmalem (Imaging Officer) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Elisa Nardone (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Carla Nell (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Maarten Spruyt (Study Designer) , EORTC Headquarters, Brussels
Maarten Spruyt (Data Manager) , EORTC Headquarters, Brussels
Eliza Starczewska (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Laurien Vancleef (Clinical Operations Manager) , EORTC Headquarters, Brussels
Maureen Vanlancker (Clinical Research Physician) , EORTC Headquarters, Brussels
Egle Venslovaite (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer Brain
Participating groups EORTC Brain Tumor Group
Recruiting centers CHU Lyon - Hopital neurologique Pierre Wertheimer (Bron, France)
Catharina Ziekenhuis (Eindhoven, Netherlands)
Erasmus MC (Rotterdam, Netherlands)
Hopital de La Timone (APHM) (Marseille, France)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
Centers to be activated Aarhus University Hospital-Skejby (Aarhus, Denmark)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy)
Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
CHRU de Lille (Lille, France)
CHRU de Lille (Lille, France)
CHU Charleroi-Marie Curie Hospital (Charleroi, Belgium)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Clatterbridge NHS -Wirral (Wirral, United Kingdom)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
Gustave Roussy (Villejuif, France)
Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
Hospital Clinic Universitari de Barcelona (Barcelona, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hospital Universitario La Fe (Valencia, Spain)
Hospital Universitario Ramon y Cajal (Madrid, Spain)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
IRCCS - Istituto Neurologico Carlo Besta (Milano, Italy)
IRCCS - Istituto Oncologico Veneto (Padova, Italy)
Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France)
Istituto Clinico Humanitas (Rozzano, Milano, Italy)
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola, Italy)
Klinikum Der J.W. Goethe Universitaet (Frankfurt Am Main, Germany)
Knappschaft Krankenhaus (Bochum-Langendreer, Germany)
Leiden University Medical Centre (Leiden, Netherlands)
Maastro Clinic - Maastricht Radiation Oncology (Maastricht, Netherlands)
Ninewells Hospital (Dundee, Scotland, United Kingdom)
Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland)
Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium)
Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
Ospedale Bellaria (Bologna, Italy)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
St. Elisabethziekenhuis TweeSteden (Tilburg, Netherlands)
UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom)
UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
UniversitaetsSpital Zurich - Neurology Clinic (Zurich, Switzerland)
Universitaetsklinik Dusseldorf (Duesseldorf, Germany)
Universitaetsklinikum Bonn (Bonn, Germany)
Universitaetsklinikum Erlangen-Schwabachanlage (Erlangen, Germany)
Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie (Freiburg, Germany)
Universitaetsklinikum Regensburg (Regensburg, Germany)
Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
University Medical Center Groningen (Groningen, Netherlands)
Western General Hospital (Edinburgh, United Kingdom)
Protocol summary http://clinicaltrials.gov/ct/show/NCT03763422
NCT number NCT03763422
EudraCT 2018-003539-31
Financial Support EORTC Group