Clinical Trial Details
EORTC-1809-STBSG
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A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)
| Trial Status | Recruiting |
|---|---|
| Dates |
Date of activation: 05-Oct-2020 |
| Data management at EORTC | Yes |
| Design |
Phase 3 Randomized open label |
| Targeted Sample size | All Groups: 240 |
| Treatment |
Surgery, Drug Dacarbazine, Ifosfamide, Adriamycin, Epiadriamycin |
| Study Staff |
Alessandro Gronchi (Study Coordinator) , IRCCS - Istituto Nazionale dei Tumori, Milano Winan Van Houdt (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Laura De Meulemeester (Clinical Operations Manager) , EORTC Headquarters, Brussels Angelique Deleersnijder (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Giovanna Farro (Clinical Scientist) , EORTC Headquarters, Brussels Piet Gutscoven (Data Manager) , EORTC Headquarters, Brussels Lucy Irvine (Clinical Operations Assistant) , EORTC Headquarters, Brussels Saskia Litiere (Statistician) , EORTC Headquarters, Brussels Hafida Lmalem (Imaging Officer) , EORTC Headquarters, Brussels Juliette Ly (Project Manager) , EORTC Headquarters, Brussels Eleni Mandila (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Marie Morfouace (Clinical Scientist) , EORTC Headquarters, Brussels David Ndah Aki (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Sarah Nuyens (Project Manager) , EORTC Headquarters, Brussels Axelle Nzokirantevye (Data Manager) , EORTC Headquarters, Brussels Madeline Pe (QoL Specialist) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Carmen Sobrino (Lead CRA) , 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 Eastern Cooperative Oncology Group Japan Clinical Oncology Group Canadian Cancer Trials Group Australia and New Zealand Sarcoma Association |
| Recruiting centers |
Centre Leon Berard (Lyon, France) Centro Di Riferimento Oncologico (Aviano, Italy) Gustave Roussy (Villejuif, France) Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg, France) Hospital De La Santa Creu I Sant Pau (Barcelona, Spain) Hospital Universitario San Carlos (Madrid, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) IRCCS - Fondazione Piemonte Inst di Candiolo (Candiolo (Torino), Italy) IRCCS - Istituto Nazionale dei Tumori (Milano, Italy) IRCCS - Istituto Oncologico Veneto (Padova, Italy) IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy) Institut Curie- Hopital de Paris (Paris, France) Institut du Cancer de Montpellier (Montpellier, France) Istituto Clinico Humanitas (Rozzano, Milano, Italy) Istituto Europeo di Oncologia (Milano, Italy) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Masaryk Memorial Cancer Institute (Brno, Czech Republic) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) National Cancer Institute (Bratislava, Slovakia) Policlinico Universitario Campus Bio-Medico- Oncology Center (Roma, Italy) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinikum Carl Gustav Carus (Dresden, Germany) |
| Centers to be activated |
Aarhus University Hospital-Skejby (Aarhus, Denmark) Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus) Clatterbridge NHS -Wirral (Wirral, United Kingdom) Herlev Hospital - University Copenhagen (Herlev, Denmark) Hospital General Universitario Gregorio Maranon (Madrid, Spain) Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom) Leiden University Medical Centre (Leiden, Netherlands) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom) Universitaetsmedizin Goettingen - Georg-August Universitaet (Goettingen, Germany) University College Hospital (London, United Kingdom) University Medical Center Groningen (Groningen, Netherlands) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT04031677 |
| NCT number | NCT04031677 |
| EudraCT | 2019-003543-30 |
| Financial Support |
EORTC HQ EORTC Group Anticancer Fund ECRF Sarcoma UK, Roger Wilson Research Award Cancer Research UK |
