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: 624 - All Groups: 574 |
| 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 Sylvie Ledroit (Clinical Operations Assistant) , 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 Maarten Spruyt (Data Manager) , EORTC Headquarters, Brussels Maarten Spruyt (Study Designer) , 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 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) Clatterbridge NHS -Wirral (Wirral, United Kingdom) 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 Neurologico Carlo Besta (Milano, Italy) IRCCS - Istituto Oncologico Veneto (Padova, Italy) IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy) Istituto Clinico Humanitas (Rozzano, Milano, Italy) Leiden University Medical Centre (Leiden, Netherlands) Maastro Clinic - Maastricht Radiation Oncology (Maastricht, Netherlands) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) NHS Tayside - Ninewells Hospital (Dundee, Scotland, United Kingdom) Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland) 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) Gustave Roussy (Villejuif, France) Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom) Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France) Knappschaft Krankenhaus (Bochum-Langendreer, Germany) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) 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 |