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 Emanuel Buhrer (Project Physician) , EORTC Headquarters, Brussels Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Corneel Coens (Statistician) , EORTC Headquarters, Brussels Ilse Coppens (Clinical Operations Assistant) , EORTC Headquarters, Brussels Benedicte Demeulder (Project Manager) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Piet Gutscoven (Data Manager) , EORTC Headquarters, Brussels Ana Joaquim (Project Physician) , EORTC Headquarters, Brussels Ryosuke Kita (Medical Fellow) , EORTC Headquarters, Brussels Stephanie Kromar (Senior Regulatory Affairs 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) BC Cancer (Britisch Columbia Cancer Agency) (Vancouver, Canada) Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus) Cancer Institute Hospital of JFCR (Tokyo, Japan) Carilion Roanoke Memorial Hospital (Roanoke, United States of America) Centre Leon Berard (Lyon, France) Centro Di Riferimento Oncologico (Aviano, Italy) Chris O'Brien Lifehouse (Camperdown NSW , Australia) City Of Hope National Medical Center (Duarte, United States of America) Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom) Dana-Farber Cancer Institute & Harvard Medical School (Boston, United States of America) Duke University Medical Center (Durham, United States of America) Emory University Hospital Midtown (Atlanta, United States of America) Fox Chase Medical Center (Philadelphia, United States of America) Fred Hutchinson Cancer Center- South Lake Union (Seattle, United States of America) Fred Hutchison Seattle Cancer Care Alliance (Seattle, United States of America) Froedtert and the Medical College of Wisconsin (Milwaukee, 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 General Universitario Gregorio Maranon (Madrid, Spain) Hospital Universitario San Carlos (Madrid, Spain) Hospital of the University of Pennsylvania (Philadelphia, United States of America) 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) Johns Hopkins Medicine - Kimmel Comprehensive Cancer Center (Baltimore, United States of America) 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) 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) McGill University Health Centre - Montreal General Hospital (Montreal, Canada) 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) Nebraska Medical Center (Omaha, United States of America) Nebraska Medicine - Bellevue (bellevue, United States of America) Nebraska Medicine - Village Pointe (Omaha, United States of America) Niigata University Medical & Dental Hospital (Niigata-Shi, 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) Oregon Health & Science Univ (Portland, United States of America) 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) Roswell Park Cancer Institute (Buffalo, United States of America) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) Sanford Bismarck Medical Center (Bismarck, United States of America) Sanford Broadway Medical Center (Fargo, United States of America) Sanford Cancer Center Oncology Clinic (Sioux Falls, United States of America) Sanford Joe Lueken Cancer center (Bemidji, United States of America) Sanford Roger Maris Cancer Center (Fargo, United States of America) Sanford USD Medical Center Sioux Falls (Sioux Falls, 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) Smilow Cancer Hospital Long Ridge (Stamford, United States of America) Smilow Cancer Hospital- Greenwich (Greenwich, United States of America) Smilow Cancer Hospital-Derby Care Center (Derby, United States of America) Smilow Cancer Hospital-Fairfield (Fairfield, United States of America) Smilow Cancer Hospital-Glastonbury (Glastonbury, United States of America) Smilow Cancer Hospital-Guilford (Guilford, United States of America) Smilow Cancer Hospital-North Haven (North Haven, United States of America) Smilow Cancer Hospital-Torrington (Torrington, United States of America) Smilow Cancer Hospital-Trumbull (Trumbull, United States of America) Smilow Cancer Hospital-Waterbury (Waterbury, United States of America) Smilow Cancer Hospital-Waterford (Waterford, United States of America) Smilow Cancer Hospital-Westerly (Westerly, United States of America) St. Francis Cancer Center (Hartford, United States of America) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) The Ottawa Hospital - General Campus (Ottawa, Canada) The University of Texas MD Anderson Cancer Center (Houston, United States of America) Thomas Jefferson University Hospital-Jefferson Heart Institute (Philadelphia, United States of America) Tohoku University Hospital (Sendai Miyagi, Japan) UCHealth University Colorado Hospital (Colorado , United States of America) UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom) UPMC Hillman Cancer Center (Pittsburgh, United States of America) 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 Utah - Huntsman Cancer Institute (Salt Lake City, United States of America) University of California at Irvine (Orange, United States of America) University of Illinois Hospital (Chicago, United States of America) University of Kansas Cancer Center - Overland Park (Overland Park, United States of America) University of Michigan - Rogel Cancer Center (Ann Arbor, United States of America) University of Oklahoma - Health Science Center (Oklahoma City, United States of America) University of Rochester - James P. Wilmot Cancer Center (Rochester, United States of America) University of Washington Medical Center (Seattle, United States of America) VCU Community Memorial Health Center (South Hill, United States of America) VCU Massey cancer Center Stony Point (Richmond, United States of America) VCU Massey cancer Center at Hanover Medical park (Mechanicsville, United States of America) Virginia Commonwealth University/Massey Cancer Center (Richmond, United States of America) Yale University School Of Medicine (New Haven, United States of America) Yokohama City University Hospital (Kanagawa, Japan)
Centers to be activated	Dartmouth Hitchcock Medical Center (Lebanon, United States of America) Marshfield Medical Center-EC Cancer Center (Eau Claire, United States of America) Marshfield Medical Center-Marshfield (Marshfield, United States of America) Marshfield Medical Center-Minocqua (Minocqua, United States of America) Marshfield Medical Center-Rice Lake (Rice Lake, United States of America) Marshfield Medical Center-River Region at Stevens Point (Stevens Point, United States of America) Marshfield Medical Center-Weston (Weston, United States of America) Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom) University College Hospital (London, United Kingdom) University Medical Center Groningen (Groningen, Netherlands)
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)