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
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| 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) mihaela.balanescu (at) eortc.org, EORTC Headquarters, Brussels Jessica Berger (Clinical Research Associate/Monitor) jessica.berger (at) eortc.org, EORTC Headquarters, Brussels Isabelle Blangenois (Data Manager) isabelle.blangenois (at) eortc.org, EORTC Headquarters, Brussels Enrico Clementel (QART Manager) enrico.clementel (at) eortc.org, EORTC Headquarters, Brussels Coreen Corning (QART Manager) coreen.corning (at) eortc.org, EORTC Headquarters, Brussels Denise De Wiest (Clinical Research Physician) denise.dewiest (at) eortc.org, EORTC Headquarters, Brussels Alessandro Fadel (Clinical Operations Assistant) alessandro.fadel (at) eortc.org, EORTC Headquarters, Brussels Carla Figueiredo (Pharmacovigilance Manager) carla.figueiredo (at) eortc.org, EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) beatrice.fournier (at) eortc.org, EORTC Headquarters, Brussels Thierry Gorlia (Statistician) thierry.gorlia (at) eortc.org, EORTC Headquarters, Brussels Alessandro Gugino (Project Manager) alessandro.gugino (at) eortc.org, EORTC Headquarters, Brussels Hafida Lmalem (Imaging Officer) hafida.lmalem (at) eortc.org, EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) sara.meloen (at) eortc.org, EORTC Headquarters, Brussels Maarten Spruyt (Study Designer) maarten.spruyt (at) eortc.org, EORTC Headquarters, Brussels Maarten Spruyt (Data Manager) maarten.spruyt (at) eortc.org, EORTC Headquarters, Brussels Eliza Starczewska (Regulatory Affairs Manager) eliza.starczewska (at) eortc.org, EORTC Headquarters, Brussels Tina Verschuere (Senior Clinical Operations Manager) tina.verschuere (at) eortc.org, EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) christine.debalincourt (at) eortc.org, EORTC Headquarters, Brussels |
| Type of cancer | Brain |
| Participating groups |
EORTC Brain Tumor Group Cooperative Trials Group for Neuro-Oncology |
| Recruiting centers |
AUSL Bologna - Ospedale Bellaria (Bologna, Italy) Aarhus University Hospital-Skejby (Aarhus, Denmark) Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (PARIS CEDEX 13, France) Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) CHRU de Lille (LILLE CEDEX, France) CHU Lyon - Hopital neurologique Pierre Wertheimer (BRON CEDEX, France) Catharina Ziekenhuis (Eindhoven, Netherlands) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Clatterbridge Cancer Center - 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 CEDEX 5, 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) 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 |
Austin Health - Austin hospital (Heidelberg VIC, Australia) 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 CEDEX, France) Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom) Illawarra Cancer Care Centre-Wollongong Hospital (Wollongong, Australia) Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France) Knappschaft Krankenhaus (Bochum-Langendreer, Germany) Monash Medical Centre (Clayton, Australia) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) Prince Of Wales Hospital (Randwick - Sydney, Australia) Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) Royal Adelaide Hospital (Adelaide, Australia) Royal Hobart Hospital (Hobart, Australia) Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom) Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom) Sir Charles Gairdner Hospital (Nedlands, Australia) St Vincent'S Hospital (Fitzroy (melbourne), Australia) 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) Westmead Hospital - Crown Princess Mary Cancer Center (Westmead, Australia) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT03763422 |
| NCT number | NCT03763422 |
| EudraCT | 2018-003539-31 |