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 Christine Olungu (Data Manager) , EORTC Headquarters, Brussels Miguel Remis (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Ionela Stanciu (Clinical Operations Manager) , EORTC Headquarters, Brussels Xiao Mang Zhou (Junior RAM) , 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 CEDEX, France) Gustave Roussy (VILLEJUIF CEDEX, France) Hopital de La Timone (APHM) (MARSEILLE CEDEX 5, 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 CEDEX 05, France) Leiden University Medical Centre (Leiden, Netherlands) Maria Sklodowska-Curie National Research Institute of Oncology (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 |
