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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
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
NCT number NCT04031677
EudraCT 2019-003543-30
Financial Support EORTC HQ
Anticancer Fund
Sarcoma UK, Roger Wilson Research Award
Cancer Research UK
Novo Nordisk Foundation
Institut National du Cancer (INCA)
Climbers Against Cancer (CAC)