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, CCNU
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
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
Gilles Sarlet (Regulatory Affairs Manager) gilles.sarlet (at) eortc.org, EORTC Headquarters, Brussels
Maureen Vanlancker (Project 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 Trial 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
Alliance
Recruiting centers Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (Marseille, France)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France)
CHU Ucl Namur - Site Sainte-Elisabeth (Namur, Belgium)
Centre Antoine Lacassagne (Nice, France)
Centre Georges-Francois-Leclerc (Dijon, France)
Centre Leon Berard (Lyon, France)
Erasmus MC (Rotterdam, Netherlands)
Gustave Roussy (Villejuif, France)
Kepler University Hospital (Linz, Austria)
Maastro Clinic - Maastricht Radiation Oncology (Maastricht, Netherlands)
Medical University Vienna - General Hospital AKH (Vienna, Austria)
Ospedale Bellaria (Bologna, Italy)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
University Medical Center Groningen (Groningen, Netherlands)
Vrije Universiteit Medisch Centrum (Amsterdam, Netherlands)
Vrije Universiteit Medisch Centrum (Amsterdam, Netherlands)
ZNA Middelheim (Antwerpen, Belgium)
Centers to be activated Alfred Hospital (Prahran, Australia)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy)
Billings clinic cancer center (Billings, United States of America)
CHRU de Lille (Lille, France)
Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
Catharina Ziekenhuis (Eindhoven, Netherlands)
Flinders Medical Centre (Bedford Park, Australia)
Fondazione IRCCS Istituto Neurologico Carlo Besta (Milano, Italy)
Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
Hacettepe University School of Medicine (Ankara, Turkey)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
Innsbruck Universitaetsklinik (Innsbruck, Austria)
Institut régional du Cancer Montpellier (Montpellier, France)
Istituto Oncologico Veneto IRCCS (Padova, Italy)
Klinikum Der J.W. Goethe Universitaet (Frankfurt Am Main, Germany)
Liverpool Hospital (Liverpool, Australia)
Medisch Centrum Haaglanden - Westeinde (Den Haag, Netherlands)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Prince Of Wales Hospital (Randwick - Sydney, Australia)
Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia)
Royal Hobart Hospital (Hobart, Australia)
Royal Marsden Hospital - Sutton, Surrey (Sutton, United Kingdom)
S.B. Marmara Univesitesi Pendik Egitim ve Arastirma Hastanesi (Istanbul, Turkey)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
Sir Charles Gairdner Hospital (Nedlands, Australia)
Skane University Hospital (Lund, Sweden)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Royal Surrey County Hospital NHS Foundation Trust (Guildford, United Kingdom)
UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom)
Umea Universitet (Umea, Sweden)
Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea (Roma, Italy)
UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinik Erlangen-Neurologische Klinik (Erlangen, Germany)
Universitaetskliniken Regensburg (Regensburg, Germany)
Universitaetsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie (Leipzig, Germany)
Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
Universitair Medisch Centrum - Academisch Ziekenhuis (Utrecht, Netherlands)
University College Hospital (London, United Kingdom)
University of Oklahoma - Health Science Center (Oklahoma City, United States of America)
Western General Hospital (Edinburgh, United Kingdom)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00887146
NCT number NCT00887146
EudraCT 2008-007295-14