Clinical Trial Details

EORTC-1608-BTG

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Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients with Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 06-Jun-2018
Date Step1 close: 27-Jul-2021
Date Step2 close: 27-Jul-2021
Data management at EORTC Yes
Design Phase 1
Not randomized / N.A.
Targeted Sample size EORTC Groups: 81 - All Groups: 81
Treatment Radiotherapy, Drug
Temozolomide, TG02
Study Staff Emilie Le Rhun (Study Coordinator) , UniversitaetsSpital Zurich - Neurology Clinic, Zurich
Jose Casas (TR Scientist) , EORTC Headquarters, Brussels
Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels
Coreen Corning (QART Manager) , EORTC Headquarters, Brussels
Ruxandra Dionisie (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels
Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels
Hafida Lmalem (Imaging Officer) , EORTC Headquarters, Brussels
Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Axelle Nzokirantevye (Imaging DM) , EORTC Headquarters, Brussels
Maarten Spruyt (Data Manager) , EORTC Headquarters, Brussels
Eliza Starczewska (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Tina Verschuere (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer Brain
Participating groups EORTC Brain Tumor Group
Recruiting centers CHRU de Lille (LILLE CEDEX, France)
CHU Lyon - Hopital neurologique Pierre Wertheimer (BRON CEDEX, France)
Erasmus MC (Rotterdam, Netherlands)
Gustave Roussy (VILLEJUIF CEDEX, France)
Hopital de La Timone (APHM) (MARSEILLE, France)
UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinikum Bonn (Bonn, Germany)
Universitaetsklinikum Regensburg (Regensburg, Germany)
Universitaetsklinikum Wien - AKH unikliniken (Vienna, Austria)
University Hospital Frankfurt -Senckenberg Institute of Neurooncology (Frankfurt am Main, Germany)
Protocol summary http://clinicaltrials.gov/study/NCT03224104
NCT number NCT03224104
EudraCT 2017-001029-42
Financial Support Educational Grant