Study
EORTC-1809-STBSG
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
Randomized open label
Targeted Sample size
All Groups: 240
Treatment
Surgery, Drug
Dacarbazine, Doxorubicin, Epirubicin, Ifosfamide
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
- Corneel Coens (Statistician), EORTC Headquarters, Brussels
- Amaya Gonzalez (Junior Clinical Operations Manager), 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
- Alexandra Latteux (Clinical Operations Assistant), EORTC Headquarters, Brussels
- Stephane Lejeune (International Affairs and Policies Manager), EORTC Headquarters, Brussels
- Niels Lema (Clinical Data Expert), 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
- Camila Matiollo (Data Manager), 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
- Victoria Ossorio (Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
- Madeline Pe (QoL Specialist), EORTC Headquarters, Brussels
- Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Tetsuya Sekita (Medical Fellow), EORTC Headquarters, Brussels
- Zineb Wadid (Lead CRA), EORTC Headquarters, Brussels
- Xiao Mang Zhou (Regulatory Affairs Manager), 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)
- Allegheny General Hospital (Pittsburgh, United States of America)
- Allegheny Valley Hospital (Natrona Heights, United States of America)
- 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 Comprehensive Cancer Center (Duarte, United States of America)
- Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom)
- Dana-Farber/Harvard Cancer Center (Boston, United States of America)
- Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr (Lebanon, United States of America)
- Duke University Medical Center (Durham, United States of America)
- Emory University Hospital Midtown (Atlanta, United States of America)
- Forbes Hospital (Monroeville, United States of America)
- Fox Chase Cancer Center (Philadelphia, United States of America)
- Fred Hutchinson Cancer Center (Seattle, United States of America)
- Fred Hutchinson Cancer Center- South Lake Union (Seattle, United States of America)
- Gustave Roussy (VILLEJUIF CEDEX, France)
- Hackensack University Medical Center (New Jersey, 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)
- 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 - Istituto Oncologico Veneto (Padova, Italy)
- IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy)
- Indiana University Simon Comprehensive Cancer Center (Indianapolis, United States of America)
- 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)
- James Graham Brown Ca Ctr at Univ of Louisville (Louisville, United States of America)
- Jefferson Hospital (Jefferson Hills, United States of America)
- Jichi Medical University Saitama Medical Center (Saitama, Japan)
- Kanagawa Cancer Center (Kanagawa, Japan)
- Kyushu University Hospital (Fukuoka, Japan)
- LSU Health Baton Rouge North Clinic (Baton Rouge, United States of America)
- Laura and Isaac Perlmutter Ca Ctr at NYU Langone (New York, 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)
- M D Anderson Cancer Center (Houston, United States of America)
- Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
- 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)
- 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)
- Medical College of Wisconsin (Milwaukee, United States of America)
- Moffit Cancer Center - International Plazza (Tampa, United States of America)
- Moffit cancer Center - McKinley Campus (Tampa, United States of America)
- Moffitt Cancer Center (Tampa (FL), 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)
- NYU Langone Hospital - Long Island (Mineola, United States of America)
- Nagoya University Hospital (Nagoya, Japan)
- Narodny Onkologicky Ustav - Bratislava (Bratislava, Slovakia)
- National Cancer Center - Hospital Tokyo (Tokyo, Japan)
- 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)
- Northwestern University (Chicago, United States of America)
- Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
- Ohio State University Comprehensive Cancer 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)
- Pennsylvania Hospital (Philadelphia, United States of America)
- 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)
- Rhode Island Hospital / Brown University (Providence, United States of America)
- Roswell Park Cancer Institute (Buffalo, United States of America)
- Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
- Saint Vincent Hospital (Erie, United States of America)
- 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-South Country (St Louis, United States of America)
- Siteman Cancer Center-West county (Creve Coeur, United States of America)
- Smilow Cancer Hospital Care Center - Waterford (Waterford, United States of America)
- Smilow Cancer Hospital Care Center - Westerly (Westerly, United States of America)
- Smilow Cancer Hospital Care Center Greenwich (Greenwich, United States of America)
- Smilow Cancer Hospital Care Center Guilford (Guilford, United States of America)
- Smilow Cancer Hospital Care Center Trumbull (Trumbull, United States of America)
- Smilow Cancer Hospital Care Center at Glastonbury (Glastonbury, United States of America)
- Smilow Cancer Hospital Care Center at Long Ridge (Stamford, United States of America)
- Smilow Cancer Hospital Care Center-Fairfield (Fairfield, United States of America)
- Smilow Cancer Hospital Care Ctr at Saint Francis (Hartford, United States of America)
- Smilow Cancer Hospital-Derby Care Center (Derby, United States of America)
- Smilow Cancer Hospital-Torrington Care Center (Torrington, United States of America)
- Smilow Cancer Hospital-Waterbury Care Center (Waterbury, United States of America)
- Stony Brook University Hospital (New York, United States of America)
- The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
- The Ottawa Hospital - General Campus (Ottawa, Canada)
- Thomas Jefferson University Hospital (Philadelphia, United States of America)
- Tohoku University Hospital (Sendai Miyagi, Japan)
- UC Irvine Health/Chao Family Comprehensive Ca Ctr (Orange, United States of America)
- UCHealth University Colorado Hospital (Colorado , United States of America)
- UCI Health-Chao Family Comp CC and Ambulatory Care (Irvine, United States of America)
- UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom)
- UPMC Hillman Cancer Center (Pittsburgh, United States of America)
- UT Southwestern/Simmons Cancer Center- Dallas (Dallas, United States of America)
- Univ of Illinois at Chicago MBCCOP (Chicago, 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 Kansas Cancer Center - Overland Park (Overland Park, United States of America)
- University of Kansas Hospital - Westwood Cancer Ctr (Westwood, United States of America)
- University of Michigan Comprehensive Cancer Center (Ann Arbor, United States of America)
- University of Nebraska Medical Center (Omaha, United States of America)
- University of Oklahoma - Health Science Center (Oklahoma City, United States of America)
- University of Pennsylvania - Abramson Cancer Center (Philadelphia, United States of America)
- University of Rochester (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)
- Vanderbilt University/Ingram Cancer Center (Nashville, United States of America)
- Virginia Commonwealth University/Massey Cancer Center (Richmond, United States of America)
- West Penn Hospital (Pittsburgh, United States of America)
- Wexford Health and Wellness Pavilion (Wexford, United States of America)
- Yale University (New Haven, United States of America)
- Yale-New Haven Hospital North Haven Medical Center (North Haven, United States of America)
- Yokohama City University Hospital (Kanagawa, Japan)
Centers to be activated
- Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom)
- University Medical Center Groningen (Groningen, Netherlands)
Protocol summary
NCT number
NCT04031677