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	All trial activities ended
Dates	Date of activation: 12-Mar-2020 Date Step1 close: 29-Oct-2021
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 Jessica Berger (Clinical Research Associate/Monitor) , 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 Hafida Lmalem (Imaging Officer) , 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 Tina Verschuere (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer	Brain
Participating groups	EORTC Brain Tumor Group Cooperative Trials Group for Neuro-Oncology
Recruiting centers	APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) AUSL Bologna - Ospedale Bellaria (Bologna, Italy) CHRU de Lille (LILLE CEDEX, France) CHU Lyon - Hopital neurologique Pierre Wertheimer (BRON CEDEX, France) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom) ETZ - St. Elisabethziekenhuis (Tilburg, Netherlands) 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 de Barcelona (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital Universitario Ramon y Cajal (Madrid, Spain) Hospital Universitario Y Politecnico La Fe (Valencia, 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) Region Midtjylland - Aarhus University Hospital-Skejby (Aarhus, Denmark) Stichting Catharina Ziekenhuis (Eindhoven, Netherlands) Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) UniversitaetsSpital Zurich - Neurology Clinic (Zurich, Switzerland) Universitaetsklinikum Wien - AKH unikliniken (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) 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 Elizabeth Medical Centre (Birmingham, United Kingdom) UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands) Univ. Knappschaft Krankenhaus Bochum (Bochum-Langendreer, Germany) 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/study/NCT03763422
NCT number	NCT03763422
EudraCT	2018-003539-31
Financial Support	EORTC Group