Clinical Trial Details
EORTC-1403-STBSG
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International Randomised Controlled Trial of Chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma
Trial Status | Closed to Patient Entry |
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Dates |
Date of activation: 10-Mar-2016 Date Step1 close: 03-Dec-2021 |
Data management at EORTC | No |
Design |
Phase 2-3 Randomized open label |
Targeted Sample size | EORTC Groups: 100 - All Groups: 500 |
Treatment |
Drug Cyclophosphamide, Docetaxel, Gemcitabine, Ifosfamide, Irinotecan, Temozolomide, Topotecan |
Study Staff |
Uta Dirksen (Study Coordinator) , Universitaetsklinikum - Essen, Essen Martin McCabe (Study Coordinator) , The Christie NHS Foundation Trust, Manchester Corneel Coens (Statistician) , EORTC Headquarters, Brussels Bianca Colleoni (Clinical Operations Manager) , EORTC Headquarters, Brussels Niels Lema (Clinical Data Expert) , EORTC Headquarters, Brussels Saskia Litiere (Statistician) , EORTC Headquarters, Brussels Juliette Ly (Project Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Zara Nasir (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Miriam Presas (Junior RAM) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Ionela Stanciu (Clinical Operations Manager) , EORTC Headquarters, Brussels Zineb Wadid (Lead CRA) , EORTC Headquarters, Brussels Xiao Mang Zhou (Junior RAM) , EORTC Headquarters, Brussels |
Type of cancer | Ewing Sarcoma |
Participating groups |
EORTC Soft Tissue and Bone Sarcoma Group Scandinavian Sarcoma Group Italian Sarcoma Group Gesellschaft fuer Paediatrische Onko. & Haemato. - Germany Grupo Espanol de Investigacion en sarcomas University of Birmingham - CRUK Swiss Paediatric Oncology Group |
Recruiting centers |
APHP Sorbonne Univ - Hopital Armand Trousseau (PARIS, France) Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands) CHC - Clinique de l'Esperance (Saint-Nicolas (Montegnee), Belgium) CHC MontLegia (Liege, Belgium) CHRU de Nancy - Hopitaux De Brabois (VANDOEUVRE LES NANCY CEDEX, France) CHU De Toulouse - Hopital Des Enfants (TOULOUSE CEDEX 3, France) CHU Montpellier-Hopital Arnaud De Villeneuve (MONTPELLIER CEDEX 5, France) CHU de Nantes - Hopital femme-enfant-adolescent (NANTES CEDEX 1, France) CHU de Nice - Hopital De L'Archet (NICE, France) CHU de Rouen - Hopital Charles Nicolle (ROUEN CEDEX, France) CHU de Tours - Hopital Bretonneau (Tours, France) Centre Georges-Francois-Leclerc (DIJON CEDEX, France) Centre Henri Becquerel (ROUEN CEDEX, France) Centre Leon Berard (Lyon, France) Centre Oscar Lambret (LILLE CEDEX, France) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Gustave Roussy (VILLEJUIF CEDEX, France) Hopital de La Timone (APHM) (MARSEILLE CEDEX 5, France) Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg Cedex 1, France) Institut Bergonie (Bordeaux, France) Institut Curie- Hopital de Paris (PARIS CEDEX 05, France) Institut Jules Bordet (Anderlecht, Belgium) Institut de Cancerologie de la Loire Lucien Neuwirth (Saint Priest en Jarez, France) Institut de Cancerologie de l’Ouest (ICO) - Angers (ANGERS CEDEX 02, France) Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France) Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France) Leiden University Medical Centre (Leiden, Netherlands) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Military Hospital - State Health Centre (Budapest, Hungary) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) Universitair Ziekenhuis Brussel (Brussels, Belgium) Universitair Ziekenhuis Gent (Gent, Belgium) University Hospital Motol (Prague, Czech Republic) University Medical Center Groningen (Groningen, Netherlands) |
Protocol summary | http://clinicaltrials.gov/study/ |
NCT number | |
EudraCT | 2014-000259-99 |
Financial Support | EU Grant |