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 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 CEDEX
Wolfgang Wick (Study Coordinator) , UniversitaetsKlinikum Heidelberg - Head Hospital, Heidelberg
Isabelle Blangenois (Data Manager) , EORTC Headquarters, Brussels
Coreen Corning (QART Manager) , EORTC Headquarters, Brussels
Giuliana Crucitti (Regulatory Affairs 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
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 AUSL Bologna - Ospedale Bellaria (Bologna, Italy)
Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (PARIS CEDEX 13, France)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
Centre Antoine Lacassagne (NICE CEDEX 2, France)
Centre Georges-Francois-Leclerc (DIJON CEDEX, France)
Centre Leon Berard (Lyon, France)
Erasmus MC (Rotterdam, Netherlands)
Gustave Roussy (VILLEJUIF CEDEX, France)
Hopital de La Timone (APHM) (MARSEILLE CEDEX 5, France)
Kepler University Hospital (Linz, Austria)
Maastro Clinic - Maastricht Radiation Oncology (Maastricht, Netherlands)
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