Trabectedin for Recurrent Grade II/III Meningioma
- Conditions
- Recurrent High Grade Meningioma
- Interventions
- Other: Local standard of careDrug: Trabectedin
- Registration Number
- NCT02234050
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Brief Summary
The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.
- Detailed Description
This is a randomized open label multicenter comparative phase II trial. The objective of the study is to investigate whether trabectedin demonstrates sufficient antitumor activity against recurrent grade II or III to justify further investigation in phase III or as adjuvant therapy for newly diagnosed disease after resection and radiotherapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Local standard of care Local standard of care Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care. Trabectedin Trabectedin Patient will be treated with trabectedin
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first
- Secondary Outcome Measures
Name Time Method Progression Free Survival at 6 months (PFS-6), median PFS (mPFS) From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS) From the date of randomization up to the date of death, up to 12 months Health-related Quality of life (HRQol) Untill six months after randomization Safety (CTCAE v.4.0) From randomization up to 30 days after administration of the last dose of protocol treatment or until the start of a new antitumor therapy, whichever occurs first. Best overall response (BOR). Objective response (CR/PR), rate and median duration. Complete response (CR), rate and median duration. From the date of randomization until disease progression
Trial Locations
- Locations (47)
Landesnervenklinik Wagner Jauregg
🇦🇹Linz, Austria
U.Z. Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
CHU Dinant Godinne - UCL Namur
🇧🇪Yvoir, Belgium
CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer
🇫🇷Bron, France
Centre Georges-Francois-Leclerc
🇫🇷Dijon, France
CHRU de Lille
🇫🇷Lille, France
Centre Leon Berard
🇫🇷Lyon, France
CHU de Nice - Hopital Pasteur
🇫🇷Nice, France
Centre Eugene Marquis
🇫🇷Rennes, France
Gustave Roussy
🇫🇷Villejuif, France
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital
🇩🇪Heidelberg, Germany
Klinikum Der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
Universitaetsklinikum Muenster, Zentralklinikum
🇩🇪Muenster, Germany
Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern
🇩🇪Muenchen, Germany
Universitaetskliniken Regensburg
🇩🇪Regensburg, Germany
Eberhard Karls Universitaet Tuebingen - Universitaetsklinikum Tuebingen
🇩🇪Tubingen, Germany
Istituto Oncologico Veneto IRCCS - Ospedale Busonera
🇮🇹Padova, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze
🇮🇹Torino, Italy
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Erasmus MC Cancer Institute - location Daniel den Hoed
🇳🇱Rotterdam, Netherlands
Oslo University Hospital - Radiumhospitalet
🇳🇴Oslo, Norway
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital Clinic Universitari de Barcelona
🇪🇸Barcelona, Spain
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
🇪🇸Barcelona, Spain
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Centre Hospitalier Universitaire Vaudois - Lausanne
🇨🇭Lausanne, Switzerland
UniversitaetsSpital Zurich
🇨🇭Zurich, Switzerland
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
🇬🇧Bristol, United Kingdom
NHS Lothian - Western General Hospital
🇬🇧Edinburgh, United Kingdom
Guy's and St Thomas' NHS - St Thomas Hospital
🇬🇧London, United Kingdom
Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care
🇬🇧Newcastle, United Kingdom
Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie
🇩🇪Freiburg, Germany
Istituto Regina Elena / Istituti Fisioterapici Ospitalieri
🇮🇹Roma, Italy
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Spaarne Gasthuis - Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Medical University Vienna - General Hospital AKH
🇦🇹Vienna, Austria
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Institut régional du Cancer Montpellier
🇫🇷Montpellier, France
Universitaetsklinikum - Essen
🇩🇪Essen, Germany
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
🇫🇷Paris, France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
🇫🇷Bordeaux, France