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A phase II multicenter study comparing the efficacy of the oral angiogenesis inhibitor nintedanib with the intravenous cytotoxic compound ifosfamide for treatment of patients with advanced metastatic soft tissue sarcoma after failure of systemic non-oxazaphosporine-based first line chemotherapy for inoperable disease "ANITA"

Study documentation

Trial Status Recruiting
Dates Date of activation: 07-Jul-2017
Data management at EORTC Yes
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 158 - All Groups: 158
Treatment Drug
Ifosfamide, Nintedanib
Study Staff Patrick Schoeffski (Study Coordinator) , U.Z. Leuven - Campus Gasthuisberg, Leuven
Laura De Meulemeester (Clinical Operations Manager) laura.demeulemeester (at), EORTC Headquarters, Brussels
Marianna Del Sole (Clinical Research Associate/Monitor) marianna.delsole (at), EORTC Headquarters, Brussels
Saskia Litiere (Statistician) saskia.litiere (at), EORTC Headquarters, Brussels
Arne Maes (Clinical Research Associate/Monitor) arne.maes (at), EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at), EORTC Headquarters, Brussels
Elisa Nardone (Regulatory Affairs Administrator) elisa.nardone (at), EORTC Headquarters, Brussels
Sara Nicolas (Regulatory Affairs Manager) sara.nicolas (at), EORTC Headquarters, Brussels
Jean-Paul Nzanzu (Clinical Research Associate/Monitor) jean-paul.nzanzu (at), EORTC Headquarters, Brussels
Christine Olungu (Data Manager) christine.olungu (at), EORTC Headquarters, Brussels
Miguel Remis (Clinical Research Associate/Monitor) miguel.remis (at), EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) sandrine.rivrain (at), EORTC Headquarters, Brussels
Lucia Senna (Clinical Operations Assistant) lucia.senna (at), EORTC Headquarters, Brussels
Ionela Stanciu (Junior Clinical Operations Manager) ionela.stanciu (at), EORTC Headquarters, Brussels
Type of cancer Soft Tissue and Bone Sarcoma
Participating groups EORTC Soft Tissue and Bone Sarcoma Group
Recruiting centers Centre Leon Berard (Lyon, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Gustave Roussy (Villejuif, France)
Hospital Universitario San Carlos (Madrid, Spain)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
Inselspital (Bern, Switzerland)
Institut Bergonie (Bordeaux, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
Leiden University Medical Centre (Leiden, Netherlands)
Maria Sklodowska-Curie Memorial Cancer Centre (Warsaw, Poland)
Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
University College Hospital (London, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
Vilnius University Hospital Santariskiu Santaros Clinics Klinikos (Vilnius, Lithuania)
Centers to be activated Assaf Harofeh Medical Center (Zerifin, Israel)
Tel Aviv Sourasky Medical Center (Tel Aviv, Israel)
Protocol summary
NCT number NCT02808247
EudraCT 2016-002093-12