Clinical Trial Details
EORTC-1447-STBSG
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Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma
| Trial Status | All trial activities ended |
|---|---|
| Dates |
Date of activation: 21-Aug-2017 Date Step1 close: 29-Aug-2018 |
| Data management at EORTC | Yes |
| Design |
Phase 3 Randomized open label |
| Targeted Sample size | EORTC Groups: 90 - All Groups: 90 |
| Treatment |
Drug Trabectedin |
| Study Staff |
Hans (Andre Johan) Gelderblom (Study Coordinator) , Leiden University Medical Centre, Leiden Laura De Meulemeester (Clinical Operations Manager) , EORTC Headquarters, Brussels Stephanie Kromar (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Saskia Litiere (Statistician) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels Jean-Paul Nzanzu (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Christine Olungu (Data Manager) , EORTC Headquarters, Brussels Miguel Remis (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Lucia Senna (Clinical Operations Assistant) , EORTC Headquarters, Brussels Ionela Stanciu (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Xiao Mang Zhou (Regulatory Affairs Administrator) , 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) Centre Oscar Lambret (Lille, France) Gustave Roussy (Villejuif, France) Hopital de La Timone (APHM) (Marseille, France) Hospital Universitario San Carlos (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) Institut Bergonie (Bordeaux, France) Institut Curie- Hopital de Paris (Paris, France) Leiden University Medical Centre (Leiden, Netherlands) Maria Sklodowska Curie - Curie’s National Institute of Oncology – National Research Institute (Warsaw, Poland) Medizinische Hochschule Hannover (Hannover, Germany) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) UniversitaetsMedizin Mannheim (Mannheim, Germany) University Medical Center Groningen (Groningen, Netherlands) |
| Centers to be activated |
Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus) IRCCS - Fondazione Piemonte Inst di Candiolo (Candiolo (Torino), Italy) Policlinico Universitario Campus Bio-Medico- Oncology Center (Roma, Italy) University Hospital Virgen del Rocio (Sevilla, Spain) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT02929394 |
| NCT number | NCT02929394 |
| EudraCT | 2016-003535-38 |
| Financial Support | Educational Grant |