Clinical Trial Details

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 Recruiting
Dates Date of activation: 26-Jul-2018
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
Christine Bastin (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
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
Sven Janssen (Data Manager) , EORTC Headquarters, Brussels
Stephanie Kromar (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Sylvie Ledroit (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Niels Lema (Study Designer) , EORTC Headquarters, Brussels
Arianne Marrez (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Lore Meelberghs (Data Manager) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Marie Morfouace (Clinical Scientist) , EORTC Headquarters, Brussels
Sarah Nuyens (Project Manager) , EORTC Headquarters, Brussels
Axelle Nzokirantevye (Imaging DM) , EORTC Headquarters, Brussels
Arnaud Poncin (Data Manager) , EORTC Headquarters, Brussels
Carmen Sobrino (Lead CRA) , EORTC Headquarters, Brussels
Corinne Sokeng (Data Manager) , EORTC Headquarters, Brussels
Laurien Vancleef (Clinical Operations Manager) , EORTC Headquarters, Brussels
Maureen Vanlancker (Clinical Research Physician) , EORTC Headquarters, Brussels
Tim Verbiest (Data Manager) , EORTC Headquarters, Brussels
Zineb Wadid (Lead CRA) , EORTC Headquarters, Brussels
Xiao Mang Zhou (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer Brain
Participating groups EORTC Brain Tumor Group
North Central Cancer Treatment Group
Cooperative Trials Group for Neuro-Oncology
Canadian Cancer Trials Group
Recruiting centers Aarhus University Hospital-Skejby (Aarhus, Denmark)
Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
Allan Blair Cancer Centre (Regina, Saskatchewan, Canada)
Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France)
BC 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, France)
CHU Lyon - Hopital neurologique Pierre Wertheimer (Bron, France)
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ) (Quebec, Canada)
CHUM - Hopital Notre-Dame (Montreal, Canada)
Cancercare Manitoba (Winnipeg, Canada)
Catharina Ziekenhuis (Eindhoven, Netherlands)
Centre Hospitalier Departemental Vendee (La Roche Sur Yon, 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)
Erasmus MC (Rotterdam, Netherlands)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium)
Gustave Roussy (Villejuif, France)
Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
Hamilton Health Sciences, Juravinski Cancer Centre (Hamilton, Canada)
Hopital Du Sacre-Coeur De Montreal (Montreal, Quebec, Canada)
Hopital Universitaires Erasme (Brussels, Belgium)
Hospital Clinic Universitari de Barcelona (Barcelona, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
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)
Innsbruck Universitaetsklinik (Innsbruck, Austria)
Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France)
John Wayne Cancer Institute (Santa Monica, United States of America)
Kantonsspital St Gallen (St Gallen, Switzerland)
Kepler University Hospital (Linz, Austria)
Kingston Health Sciences Centre (Kingston, Canada)
Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie (Frankfurt, 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)
Odette Cancer Centre - Sunnybrook Health Sciences Centre (Toronto, 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)
Regional Cancer Program of Hopital Reg. de Sudbury Reg. Hospital (Sudbury, Ontario, Canada)
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)
St. Elisabethziekenhuis TweeSteden (Tilburg, Netherlands)
Technische Universitaet Muenchen - Klinikum Rechts Der Isar (Muenchen, Germany)
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 uniklinieken (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 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)
Western General Hospital (Edinburgh, United Kingdom)
Windsor Regional Cancer Centre (Windsor, Ontario, Canada)
Centers to be activated Hopital De Jolimont (Haine St Paul, Belgium)
Saskatoon Cancer Centre (Saskatoon, Saskatchewan, Canada)
UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom)
UKE - University Cancer Center (Hamburg, Germany)
Umea - Norrlands- Universitetssjukhus (Umea, Sweden)
Protocol summary http://clinicaltrials.gov/ct/show/NCT03345095
NCT number NCT03345095
EudraCT 2017-003908-50
Financial Support Educational Grant