Study

EORTC-1709-BTG

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 Back to result

Trial Status

LT-FU ongoing

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
Sarah Nuyens (Project Manager), EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician), EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
Thierry Gorlia (Statistician), EORTC Headquarters, Brussels
Nitish Jha (Statistician), EORTC Headquarters, Brussels
Fanny Grillet (TR Scientist), EORTC Headquarters, Brussels
Ellen Peeters (Clinical Operations Manager), EORTC Headquarters, Brussels
Sven Janssen (Data Manager), EORTC Headquarters, Brussels
Lore Meelberghs (Data Manager), EORTC Headquarters, Brussels
Arnaud Poncin (Data Manager), EORTC Headquarters, Brussels
Tim Verbiest (Data Manager), EORTC Headquarters, Brussels
Niels Lema (Study Designer), EORTC Headquarters, Brussels
Axelle Nzokirantevye (Imaging DM), EORTC Headquarters, Brussels
Maarten Spruyt (Imaging DM), EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager), EORTC Headquarters, Brussels
Denisse Tubay (Pharmacovigilance Manager), EORTC Headquarters, Brussels
Stephanie Kromar (Regulatory Affairs Manager), EORTC Headquarters, Brussels
Zineb Wadid (Lead CRA), EORTC Headquarters, Brussels
Katrien Baus (Admin. assistant DM), EORTC Headquarters, Brussels
Tsvetelina Stefanova (Admin. assistant DM), EORTC Headquarters, Brussels
Enrico Clementel (RTQA Manager), EORTC Headquarters, Brussels
Coreen Corning (RTQA Officer), 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)
AZORG (previous Onze Lieve Vrouw ZK) (Aalst, Belgium)
Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
Allan Blair Cancer Centre (Regina, Saskatchewan, Canada)
Amsterdam UMC stichting - locatie VUMC (Amsterdam, Netherlands)
Arthur J.E. Child Comprehensive Cancer Centre (former Tom Baker Cancer Center) (Calgary, Canada)
BC Cancer (British 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/Harvard Cancer Center (Boston, United States of America)
ETZ - St. Elisabethziekenhuis (Tilburg, Netherlands)
Erasmus MC (Rotterdam, Netherlands)
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)
HOCH Health Ostschweiz-Kantonsspital St Gallen (St Gallen, Switzerland)
HUB-Hopital Erasme (Brussels, Belgium)
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)
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)
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)
Medical University of Vienna, University Hospital AKH Vienna (Vienna, Austria)
NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
Odette Cancer Centre - Sunnybrook Health Sciences Centre (Toronto (Ontario), Canada)
Ohio State University Cancer Center (Columbus, United States of America)
Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
Ottawa Hospital 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)
UC Irvine Health/Chao Family Comprehensive Ca Ctr (Orange, United States of America)
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)
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany)
Universitair Ziekenhuis Gent (Gent, Belgium)
University Health Network / Princess Margaret Cancer Center (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 Florida Health Science Center- Gainesville (Gainesville, United States of America)
Windsor Regional Cancer Centre (Windsor, Ontario, Canada)
ZAS Augustinus (previous GZA) (Wilrijk, Belgium)

Centers to be activated

CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
Norrlands- Universitetssjukhus (Umea, Sweden)
Saskatoon Cancer Centre (Saskatoon, Saskatchewan, Canada)
UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom)
Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)

Protocol summary

http://clinicaltrials.gov/study/NCT03345095

NCT number

NCT03345095

EudraCT

2017-003908-50