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
| 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 (Junior RAM) , 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 Arianne Marrez (Clinical Operations Manager) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Carla Nell (Junior Clinical Operations Manager) , 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 |
AUSL Bologna - Ospedale Bellaria (Bologna, Italy) Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France) Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) CHRU de Lille (Lille, France) CHU Lyon - Hopital neurologique Pierre Wertheimer (Bron, France) Catharina Ziekenhuis (Eindhoven, Netherlands) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Erasmus MC (Rotterdam, Netherlands) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands) Hopital de La Timone (APHM) (Marseille, France) 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 Oncologico Veneto (Padova, Italy) Istituto Clinico Humanitas (Rozzano, Milano, Italy) Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola, Italy) Leiden University Medical Centre (Leiden, Netherlands) Maastro Clinic - Maastricht Radiation Oncology (Maastricht, Netherlands) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) St. Elisabethziekenhuis TweeSteden (Tilburg, Netherlands) UniversitaetsSpital Zurich - Neurology Clinic (Zurich, Switzerland) Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria) |
| Centers to be activated |
Aarhus University Hospital-Skejby (Aarhus, Denmark) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy) CHU Charleroi-Marie Curie Hospital (Charleroi, Belgium) Clatterbridge NHS -Wirral (Wirral, United Kingdom) Gustave Roussy (Villejuif, France) Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom) IRCCS - Istituto Neurologico Carlo Besta (Milano, Italy) Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France) Knappschaft Krankenhaus (Bochum-Langendreer, Germany) NHS Tayside - Ninewells Hospital (Dundee, Scotland, United Kingdom) Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) 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) UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom) UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands) UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany) 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 Hospital Frankfurt -Senckenberg Institute of Neurooncology (Frankfurt am Main, Germany) University Medical Center Groningen (Groningen, Netherlands) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT03763422 |
| NCT number | NCT03763422 |
| EudraCT | 2018-003539-31 |
| Financial Support | EORTC Group |