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 Amelie Baudhuin (Clinical Operations Assistant) , EORTC Headquarters, Brussels 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 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	Aichi Cancer Center Hospital (Aichi, Japan) Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus) Cancer Institute Hospital of JFCR (Tokyo, Japan) 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) Duke University Medical Center (Durham, United States of America) Gustave Roussy (VILLEJUIF CEDEX, France) H. Lee Moffitt Cancer Center Magnolia Campus (Tampa (FL), United States of America) 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 Clinico Humanitas (Rozzano, Milano, Italy) Istituto Europeo di Oncologia (Milano, Italy) Jichi Medical University Saitama Medical Center (Saitama, Japan) Kanagawa Cancer Center (Kanagawa, Japan) Kansas University Cancer center (Westwood, United States of America) Kyushu University Hospital (Fukuoka, Japan) LSU Health Baton Rouge North Clinic (Baton Rouge, United States of America) 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) Moffit Cancer Center - International Plazza (Tampa, United States of America) Moffit cancer Center - McKinley Campus (Tampa, United States of America) Mount Sinai Hospital (Toronto, Ontario, Canada) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Nagoya University Hospital (Nagoya, Japan) Narodny Onkologicky Ustav - Bratislava (Bratislava, Slovakia) National Cancer Center - Hospital Tokyo (Tokyo, Japan) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Ohio State University Medical Center (Columbus, United States of America) Okayama University Hospital (Okayama, Japan) Osaka International cancer Institute (Chuo-Ku Osaka, Japan) Our Lady of The Lake Physicians Group (Baton Rouge, United States of America) Our Lady of the Lake Hospital (Baton Rouge, United States of America) 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) Region Midtjylland - Aarhus University Hospital-Skejby (Aarhus, Denmark) Robert H. Lurie Comprehensive Cancer Center/ Northwestern Univ Feinberg School of Medicine (Chicago, United States of America) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) The Ottawa Hospital - General Campus (Ottawa, Canada) Tohoku University Hospital (Sendai Miyagi, Japan) UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinikum Carl Gustav Carus (TUD) (Dresden, Germany) Universitaetsmedizin Goettingen - Georg-August Universitaet (Goettingen, Germany) University Of Kansas Cancer Center- (Kansas City, United States of America) University of California at Irvine (Orange, United States of America) University of Kansas Cancer Center - Overland Park (Overland Park, United States of America) Yokohama City University Hospital (Kanagawa, Japan)
Centers to be activated	City Of Hope National Medical Center (Duarte, United States of America) Emory University Hospital Midtown (Atlanta, United States of America) Fox Chase Medical Center (Philadelphia, United States of America) Froedtert and the Medical College of Wisconsin (Milwaukee, United States of America) Hospital General Universitario Gregorio Maranon (Madrid, Spain) Mayo Clinic (Rochester, United States of America) Mayo Clinic Hospital in Arizona (Phoenix, United States of America) Mayo Clinic in Florida (Jacksonville, United States of America) Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom) Niigata University Medical & Dental Hospital (Niigata-Shi, Japan) Oregon Health & Science Univ (Portland, United States of America) Sanford Joe Lueken Cancer center (Bemidji, United States of America) Siteman Cancer Center - Barnes Jewish Hosp. (Saint Louis, United States of America) Siteman Cancer Center-West St Louis (Creve Coeur, United States of America) Siteman Cancer center- South St Louis County (St Louis, United States of America) The University of Texas MD Anderson Cancer Center (Houston, United States of America) University College Hospital (London, United Kingdom) University Medical Center Groningen (Groningen, Netherlands) University of Oklahoma - Health Science Center (Oklahoma City, United States of America) Virginia Commonwealth University/Massey Cancer Center (Richmond, United States of America)
Protocol summary	http://clinicaltrials.gov/study/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)