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, Doxorubicin, Epirubicin, Ifosfamide
Study Staff	Alessandro Gronchi (Study Coordinator) , IRCCS - Fondazione 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 Ilse Coppens (Clinical Operations Assistant) , EORTC Headquarters, Brussels Carolina Fernandes (Clinical Operations Manager) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Piet Gutscoven (Data Manager) , EORTC Headquarters, Brussels Stephane Lejeune (International Affairs and Policies Manager) , 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 Zara Nasir (Pharmacovigilance Manager) , EORTC Headquarters, Brussels David Ndah Aki (Clinical Operations Manager) , EORTC Headquarters, Brussels Axelle Nzokirantevye (Data Manager) , EORTC Headquarters, Brussels Felix Oppong (Statistician) , EORTC Headquarters, Brussels Madeline Pe (QoL Specialist) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Xiao Mang Zhou (Junior RAM) , EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Type of cancer	Soft Tissue and Bone Sarcoma
Participating groups	EORTC Soft Tissue and Bone Sarcoma Group Japan Clinical Oncology Group Canadian Cancer Trials Group Australia and New Zealand Sarcoma Association ECOG-ACRIN
Recruiting centers	Aarhus University Hospital-Skejby (Aarhus, Denmark) Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus) Centre Leon Berard (Lyon, France) Centro Di Riferimento Oncologico (Aviano, Italy) Chris O'Brien Lifehouse (Camperdown NSW , Australia) Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom) Gustave Roussy (VILLEJUIF CEDEX, France) Herlev Hospital - University Copenhagen (Herlev, Denmark) Hopital Maisonneuve Rosemont (Montreal,quebec, Canada) Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg Cedex 1, 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 Istituto Nazionale dei Tumori (Milano, Italy) IRCCS - Fondazione Piemonte Inst di Candiolo (Candiolo (Torino), Italy) IRCCS - Fondazione Piemonte Inst di Candiolo (Candiolo (Torino), 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 CEDEX 05, France) Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France) 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) London Regional Cancer Center (London, Canada) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Masaryk Memorial Cancer Institute (Brno, Czech Republic) Mount Sinai Hospital (Toronto, Ontario, Canada) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Narodny Onkologicky Ustav - Bratislava (Bratislava, Slovakia) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom) Peter Maccallum Cancer Institute (Melbourne, Australia) Policlinico Universitario Campus Bio-Medico- Oncology Center (Roma, Italy) Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) The Ottawa Hospital - General Campus (Ottawa, Canada) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinikum Carl Gustav Carus (Dresden, Germany) Universitaetsmedizin Goettingen - Georg-August Universitaet (Goettingen, Germany)
Centers to be activated	Hospital General Universitario Gregorio Maranon (Madrid, Spain) Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom) UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom) 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 Novo Nordisk Foundation Institut National du Cancer (INCA) Climbers Against Cancer (CAC)