Clinical Trial Details

EORTC-1320-BTG

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Trabectedin for recurrent grade II or III meningioma: a randomized phase II study of the EORTC Brain Tumor Group

Study documentation Publications

Trial Status Closed to Patient Entry
Dates Date of activation: 10-Jul-2015
Date Step1 close: 20-Jul-2017
Data management at EORTC Yes
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 86 - All Groups: 86
Treatment Drug
Bevacizumab, Trabectedin, Hydroxycarbamide
Study Staff Martha Brodl (Study Coordinator) , Universitaetsklinikum Wien - AKH uniklinieken, Vienna
Matthias Preusser (Study Coordinator) , Universitaetsklinikum Wien - AKH uniklinieken, Vienna
Vassilis Golfinopoulos (Clinical Research Physician) , EORTC Headquarters, Brussels
Thierry Gorlia (Statistician) , EORTC Headquarters, Brussels
Hafida Lmalem (Data Manager) , EORTC Headquarters, Brussels
Cedric Mallien (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Christine Olungu (Data Manager) , EORTC Headquarters, Brussels
Maira Seini (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Maureen Vanlancker (Clinical Research Physician) , EORTC Headquarters, Brussels
Tina Verschuere (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Zineb Wadid (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels
Xiao Mang Zhou (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Type of cancer Brain
Participating groups EORTC Brain Tumor Group
Recruiting centers Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze (Torino, Italy)
CHRU de Lille (Lille, France)
CHU Lyon - Hopital neurologique Pierre Wertheimer (Bron, France)
CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (Bordeaux, France)
CHU de Nice - Hopital Pasteur (Nice, France)
Centre Eugene Marquis (Rennes, France)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Centre Leon Berard (Lyon, France)
Erasmus MC (Rotterdam, Netherlands)
Gustave Roussy (Villejuif, France)
Hopital Universitaires Erasme (Brussels, Belgium)
Hospital Clinic Universitari de Barcelona (Barcelona, Spain)
Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
IRCCS - Istituto Neurologico Carlo Besta (Milano, Italy)
IRCCS - Istituto Oncologico Veneto (Padova, Italy)
IRCCS-Regina Elena National Cancer Center (Roma, Italy)
Institut Claudius Regaud - IUCT oncopole (Toulouse, France)
Institut du Cancer de Montpellier (Montpellier, France)
Kepler University Hospital (Linz, Austria)
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom)
Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
Ospedale San Raffaele (Milano, Italy)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UKE - University Cancer Center (Hamburg, Germany)
UniversitaetsKlinikum Heidelberg - Head Hospital (Heidelberg, Germany)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinikum - Essen (Essen, Germany)
Universitaetsklinikum Bonn (Bonn, Germany)
Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie (Freiburg, Germany)
Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie (Leipzig, Germany)
Universitaetsklinikum Muenster, Zentralklinikum (Muenster, Germany)
Universitaetsklinikum Regensburg (Regensburg, Germany)
Universitaetsklinikum Tuebingen- Crona Kliniken (Tuebingen, Germany)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Universitair Ziekenhuis Gent (Gent, Belgium)
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (Bristol, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
Protocol summary http://clinicaltrials.gov/ct/show/NCT02234050
NCT number NCT02234050
EudraCT 2014-002446-47
Financial Support Educational Grant