EORTC-1709-BTG

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A phase III trial of marizomib in combination with standard temozolomide-based radiochemotherapy versus standard temozolomide-based radiochemotherapy alone in patients with newly diagnosed glioblastoma - MIRAGE

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 26-Jul-2018 Date Step1 close: 30-Sep-2020
Data management at EORTC	Yes
Design	Phase 3 Randomized open label
Targeted Sample size	EORTC Groups: 500 - All Groups: 750
Treatment	Radiotherapy, Drug Temozolomide, Marizomib
Study Staff	Patrick Roth (Study Coordinator) , UniversitaetsSpital Zurich - Neurology Clinic, Zurich Katrien Baus (Admin. assistant DM) , 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 Fanny Grillet (TR Scientist) , EORTC Headquarters, Brussels Sven Janssen (Data Manager) , EORTC Headquarters, Brussels Stephanie Kromar (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Niels Lema (Study Designer) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Lore Meelberghs (Data Manager) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Sarah Nuyens (Project Manager) , EORTC Headquarters, Brussels Axelle Nzokirantevye (Imaging DM) , EORTC Headquarters, Brussels Arnaud Poncin (Data Manager) , EORTC Headquarters, Brussels Maarten Spruyt (Imaging DM) , EORTC Headquarters, Brussels Tsvetelina Stefanova (Admin. assistant DM) , EORTC Headquarters, Brussels Denisse Tubay (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Laurien Vancleef (Clinical Operations Manager) , EORTC Headquarters, Brussels Tim Verbiest (Data Manager) , EORTC Headquarters, Brussels Tina Verschuere (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels Zineb Wadid (Lead CRA) , EORTC Headquarters, Brussels Leen Wijnen (QART Manager) , EORTC Headquarters, Brussels Xiao Mang Zhou (Junior RAM) , EORTC Headquarters, Brussels
Type of cancer	Brain
Participating groups	EORTC Brain Tumor Group Canadian Cancer Trials Group
Recruiting centers	A.O Landeskrankenhaus - Innsbruck Universitaetsklinik (Innsbruck, Austria) APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France) Academisch Ziekenhuis Maastricht (Maastricht, Netherlands) Allan Blair Cancer Centre (Regina, Saskatchewan, Canada) Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands) BC Cancer (Britisch Columbia Cancer Agency) (Vancouver, Canada) BCCA - Abbotsford Centre (Abbotsford, Canada) Bcca - Vancouver Island Cancer Centre (Victoria, Bc, Canada) C.H.U. Sart-Tilman (Liege, Belgium) CHRU de Lille (LILLE CEDEX, France) CHU Lyon - Hopital neurologique Pierre Wertheimer (BRON CEDEX, France) CHU de Quebec-Hopital l'Enfant-Jesus (HEJ) (Quebec, Canada) CHUM - Hopital Notre-Dame (Montreal, Canada) Cancercare Manitoba (Winnipeg, Canada) Centre Hospitalier Departemental Vendee (LA ROCHE SUR YON CEDEX 9, France) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Centre Hospitalier Universitaire de Sherbrooke-Fleurimont (Sherbrooke, Canada) Centre hospitalier regional de Trois-Rivieres (Trois-Rivieres, Canada) Clinica Universitaria De Navarra (Pamplona, Spain) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Dana-Farber Cancer Institute & Harvard Medical School (Boston, United States of America) ETZ - St. Elisabethziekenhuis (Tilburg, Netherlands) Erasmus MC (Rotterdam, Netherlands) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium) Gustave Roussy (VILLEJUIF CEDEX, France) Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom) Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands) Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands) Hamilton Health Sciences, Juravinski Cancer Centre (Hamilton, Canada) Health Sciences North - Sudbury Teaching hospital (Sudbury, Ontario, Canada) Hopital Du Sacre-Coeur De Montreal (Montreal, Quebec, Canada) Hopital Universitaires Erasme (Brussels, Belgium) Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland) Hospital Clinic de Barcelona (Barcelona, Spain) Hospital Universitario 12 De Octubre (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) Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France) John Wayne Cancer Institute (Santa Monica, United States of America) Kantonsspital St Gallen (St Gallen, Switzerland) Kepler University Hospital - Neuromed campus (Linz, Austria) Kingston Health Sciences Centre (Kingston, Canada) Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar (Muenchen, Germany) London Regional Cancer Center (London, Canada) Mayo Clinic (Rochester, United States of America) Mayo Clinic Scottsdale (Scottsdale, United States of America) Mayo Clinic in Florida (Jacksonville, United States of America) McGill University Health Centre-Montreal Children Hospital (Montreal, Canada) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) Odette Cancer Centre - Sunnybrook Health Sciences Centre (Toronto (Ontario), Canada) Ohio State University Comprehensive Cancer Center (Columbus, United States of America) Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) Ottawa Health Research Institute (Ottawa, Canada) Penn State College of Medicine, Hershey Medical Center-Penn State Neuroscience Institute (Hershey, United States of America) QEII Health Sciences Centre-Capital District Health Authority (Halifax, Canada) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) Region Midtjylland - Aarhus University Hospital-Skejby (Aarhus, Denmark) Rigshospitalet (Copenhagen, Denmark) Saint John Regional Hospital (Saint John, New Brunswick, Canada) Sault Area Hospital (Sault Ste. Marie, Canada) Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom) Stichting Catharina Ziekenhuis (Eindhoven, Netherlands) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) Tom Baker Cancer Centre (Calgary, Canada) UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands) UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany) UniversitaetsMedizin Mannheim (Mannheim, Germany) UniversitaetsSpital Zurich - Neurology Clinic (Zurich, Switzerland) Universitaetsklinikum Bonn (Bonn, Germany) Universitaetsklinikum Erlangen-Schwabachanlage (Erlangen, Germany) Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany) Universitaetsklinikum Regensburg (Regensburg, Germany) Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany) Universitaetsklinikum Wien - AKH unikliniken (Vienna, Austria) Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany) Universitair Ziekenhuis Gent (Gent, Belgium) University Health Network - Oci / Princess Margaret Hospital (Toronto, Canada) University Hospital Frankfurt -Senckenberg Institute of Neurooncology (Frankfurt am Main, Germany) University Medical Center Groningen (Groningen, Netherlands) University of California (San Francisco, United States of America) University of California at Irvine (Orange, United States of America) University of Florida (Gainesville, United States of America) Windsor Regional Cancer Centre (Windsor, Ontario, Canada)
Protocol summary	http://clinicaltrials.gov/study/NCT03345095
NCT number	NCT03345095
EudraCT	2017-003908-50
Financial Support	Educational Grant