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)

Study documentation

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 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 Lucia Senna (Clinical Operations Assistant) , EORTC Headquarters, Brussels Carmen Sobrino (Lead CRA) , 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) 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) 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) 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) Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
Centers to be activated	Aarhus University Hospital-Skejby (Aarhus, Denmark) Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus) Centro Di Riferimento Oncologico (Aviano, Italy) Clatterbridge NHS -Wirral (Wirral, United Kingdom) Herlev Hospital - University Copenhagen (Herlev, Denmark) Hospital General Universitario Gregorio Maranon (Madrid, Spain) Istituto Clinico Humanitas (Rozzano, Milano, Italy) Istituto Europeo di Oncologia (Milano, Italy) 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) Policlinico Universitario Campus Bio-Medico- Oncology Center (Roma, Italy) 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 Mannheim (Mannheim, Germany) Universitaetsklinikum Carl Gustav Carus (Dresden, Germany) 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