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

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 (Junior Clinical Operations Manager, 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
  • Niels Lema (Clinical Data Expert), 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
  • Zineb Wadid (Lead CRA), 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 - 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)
  • 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)
  • Indiana University Medical Center (Indianapolis, 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)
  • Rutgers Cancer Institute New Jersey (New Brunswick, United States of America)
  • Stony Brook University Hospital (New York, United States of America)
  • University College Hospital (London, United Kingdom)
  • University Medical Center Groningen (Groningen, Netherlands)
  • University of Louisville James Graham Brown Cancer Center (Louisville, United States of America)
  • Vanderbilt University Medical Center (Nashville, United States of America)

Protocol summary

NCT number

NCT04031677

EudraCT