Clinical Trial Details

EORTC-26081-BTG

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Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Study documentation

Trial Status Regulatory in Process
Dates Date of activation: 22-Dec-2010
Data management at EORTC No
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 200 - All Groups: 585
Treatment Radiotherapy, Drug
Procarbazine, Temozolomide, Vincristine, Lomustine
Study Staff Frederic Dhermain (Study Coordinator) , Gustave Roussy, Villejuif
Wolfgang Wick (Study Coordinator) , UniversitaetsKlinikum Heidelberg - Head Hospital, Heidelberg
Isabelle Blangenois (Data Manager) isabelle.blangenois (at) eortc.org, EORTC Headquarters, Brussels
Kimberley Ceulemans (Clinical Research Associate/Monitor) kimberley.ceulemans (at) eortc.org, EORTC Headquarters, Brussels
Coreen Corning (QART Manager) coreen.corning (at) eortc.org, EORTC Headquarters, Brussels
Laura De Meulemeester (Clinical Operations Manager) laura.demeulemeester (at) eortc.org, EORTC Headquarters, Brussels
Alize Devalckeneer (Junior Clinical Operations Manager) alize.devalckeneer (at) eortc.org, EORTC Headquarters, Brussels
Thierry Gorlia (Statistician) thierry.gorlia (at) eortc.org, EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at) eortc.org, EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) sara.meloen (at) eortc.org, EORTC Headquarters, Brussels
Sara Nicolas (Regulatory Affairs Manager) sara.nicolas (at) eortc.org, EORTC Headquarters, Brussels
Maureen Vanlancker (Clinical Research Physician) maureen.vanlancker (at) eortc.org, EORTC Headquarters, Brussels
Tina Verschuere (Senior Clinical Operations Manager) tina.verschuere (at) eortc.org, EORTC Headquarters, Brussels
Lorraine Wheeler (Clinical Operations Assistant) lorraine.wheeler (at) eortc.org, EORTC Headquarters, Brussels
Martin J. van den Bent (Study Co-Coordinator) , Erasmus MC , Rotterdam
Type of cancer Brain
Participating groups EORTC Brain Tumor Group
EORTC Radiation Oncology Group
North Central Cancer Treatment Group
Cooperative Trials Group for Neuro-Oncology
Alliance
Recruiting centers Amsterdam UMC - locatie VUmc (Amsterdam, Netherlands)
Amsterdam UMC - locatie VUmc (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
Centre Antoine Lacassagne (Nice, France)
Centre Georges-Francois-Leclerc (Dijon, France)
Centre Leon Berard (Lyon, France)
Centre Leon Berard (Lyon, France)
Erasmus MC (Rotterdam, Netherlands)
Gustave Roussy (Villejuif, France)
Hôpital de La Timone (APHM) (Marseille, France)
Kepler University Hospital (Linz, Austria)
Maastro Clinic - Maastricht Radiation Oncology (Maastricht, Netherlands)
Ospedale Bellaria (Bologna, Italy)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
University Medical Center Groningen (Groningen, Netherlands)
ZNA Middelheim (Antwerpen, Belgium)
Centers to be activated Alegent Health Immanuel Medical Center (Omaha, United States of America)
Alfred Hospital (Prahran, Australia)
Allan Blair Cancer Centre (Regina, Saskatchewan, Canada)
Altru Cancer Center (Grand Forks, United States of America)
Arizona Oncology Services Foundation (Phoenix, United States of America)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy)
Baptist MD Anderson Cancer Center (Jacksonville, United States of America)
Billings clinic cancer center (Billings, United States of America)
Boca Raton Regional Hospital-Lynn Cancer Institute (Boca Raton, United States of America)
CHRU de Lille (Lille, France)
CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
Catharina Ziekenhuis (Eindhoven, Netherlands)
Cedars-Sinai Medical Center (Los Angeles, United States of America)
Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame (Montreal, Canada)
Cleveland Clinic Foundation (Cleveland, United States of America)
Cleveland Clinic Foundation (Cleveland, United States of America)
Comprehensive Cancer Center - Wake Forest University (Winston-Salem, United States of America)
Essentia Health Duluth Clinic (Duluth, United States of America)
Flinders Medical Centre (Bedford Park, Australia)
Fondazione IRCCS Istituto Neurologico Carlo Besta (Milano, Italy)
Froedtert and the Medical College of Wisconsin (Milwaukee, United States of America)
Geisinger Medical Center (Danville P.A., United States of America)
Greenville Health System Cancer Institute-Eastside (Greenville, United States of America)
Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
Hennepin County Medical Center (Minneapolis, United States of America)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
Innsbruck Universitaetsklinik (Innsbruck, Austria)
Institut du Cancer de Montpellier (Montpellier, France)
Intermountain Medical Center (Murray, United States of America)
Istituto Oncologico Veneto IRCCS (Padova, Italy)
Johns Hopkins Medicine - Kimmel Comprehensive Cancer Center (Baltimore, United States of America)
Kaiser Permanente Los Angeles Medical Center (Los Angeles, United States of America)
Klinikum Der J.W. Goethe Universitaet (Frankfurt Am Main, Germany)
Liverpool Hospital (Liverpool, Australia)
Loyola University Medical Center (Maywood, United States of America)
Mayo Clinic (Rochester, United States of America)
Medical University of South Carolina (Charleston, United States of America)
Memorial Hospital of South Bend Cancer Center (South Bend, United States of America)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
Nebraska Cancer Specialists (Omaha, United States of America)
Nebraska Medical Center (Omaha, United States of America)
Northwestern University (Chicago, United States of America)
Norton Health Care Pavilion - Downtown (Louisville, United States of America)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
OSF Saint Francis Medical Center (Peoria, United States of America)
Ohio State University Comprehensive Cancer Center (Columbus, United States of America)
Oklahoma Cancer Specialists and Research Institute (Tulsa, United States of America)
Piedmont Hospital (Atlanta, United States of America)
Prince Of Wales Hospital (Randwick - Sydney, Australia)
Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia)
Rapid City Regional Hospital (Rapid City, United States of America)
Royal Hobart Hospital (Hobart, Australia)
Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom)
Saint John's Hospital - Healtheast (Maplewood, United States of America)
Saint Joseph's Hospital and Medical Center (Phoenix, United States of America)
Saint Luke's University Hospital, Bethlehem Campus (Bethlehem, United States of America)
Saint Vincent Healthcare (Billings, United States of America)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
Sir Charles Gairdner Hospital (Nedlands, Australia)
Skane University Hospital (Lund, Sweden)
Southeast Nebraska Cancer Center (Lincoln, United States of America)
Sutter Cancer Centers Radiation Oncology Services Vacaville (Fairfield, United States of America)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Royal Surrey County Hospital NHS Foundation Trust (Guildford, United Kingdom)
Thomas Jefferson University Hospital (Philadelphia, United States of America)
Tom Baker Cancer Centre (Calgary, Canada)
UC San Diego Moores Cancer Center (La Jolla, United States of America)
UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom)
UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
Umea Universitet (Umea, Sweden)
Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea (Roma, Italy)
UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
UniversitaetsSpital Zurich - Neurology Clinic (Zurich, Switzerland)
Universitaetsklinikum Erlangen-Universitaetsstr (Erlangen, Germany)
Universitaetsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie (Leipzig, Germany)
Universitaetsklinikum Regensburg (Regensburg, Germany)
Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
University College Hospital (London, United Kingdom)
University of Alabama at Birmingham (Birmingham, United States of America)
University of Florida (Gainesville, United States of America)
University of Kentuky (Lexington, United States of America)
University of Michigan (Ann Arbor, United States of America)
University of New Mexico, Cancer Care Alliance (Albuquerque, United States of America)
University of Oklahoma - Health Science Center (Oklahoma City, United States of America)
University of Rochester - James P. Wilmot Cancer Center (Rochester, United States of America)
University of Texas Medical Branch (Galveston, United States of America)
University of Texas Southwestern Medical Center (Dallas, United States of America)
University of Washington Medical Center (Seattle, United States of America)
Virginia Commonwealth University/Massey Cancer Center (Richmond, United States of America)
Walter Reed National Military Medical Center (Bethesda, United States of America)
Washington University School of Medicine - St. Louis (Saint Louis, United States of America)
West Michigan Cancer Center (Kalamazoo, United States of America)
West Virginia University (Morgantown, United States of America)
Western General Hospital (Edinburgh, United Kingdom)
Yale University School Of Medicine (New Haven, United States of America)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00887146
NCT number NCT00887146
EudraCT 2008-007295-14