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 Publications

Trial Status Closed to Patient Entry
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) , EORTC Headquarters, Brussels
Coreen Corning (QART Manager) , EORTC Headquarters, Brussels
Laura De Meulemeester (Clinical Operations Manager) , EORTC Headquarters, Brussels
Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Sara Nicolas (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Maureen Vanlancker (Clinical Research Physician) , EORTC Headquarters, Brussels
Tina Verschuere (Senior Clinical Operations Manager) , 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)
Erasmus MC (Rotterdam, Netherlands)
Gustave Roussy (Villejuif, France)
Hopital 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)
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)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00887146
NCT number NCT00887146
EudraCT 2008-007295-14
Financial Support Educational Grant