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A 3 arm randomized study on healTh-related quality Of Life of EldeRly pAtients with advaNced soft tissue sarComa undergoing doxorubicin every three weeks or doxorubicin weekly or cyclophosphamide plus predniso(lo)ne treatment

Study documentation

Trial Status Recruiting
Dates Date of activation: 11-Apr-2022
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 185 - All Groups: 185
Treatment Drug
Cyclophosphamide, Doxorubicin, Prednisolone, Prednisone
Study Staff Winette van der Graaf (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam
Laila Ben Salama (Clinical Operations Manager) , EORTC Headquarters, Brussels
Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Maarten Caspers (Data Manager) , EORTC Headquarters, Brussels
Corneel Coens (Statistician) , EORTC Headquarters, Brussels
Piet Gutscoven (Data Manager) , EORTC Headquarters, Brussels
Olga Husson (Study Co-Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam
Gloria Marquina (Y-ECI Coordinator) , Hospital Universitario San Carlos, Madrid
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels
Zara Nasir (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Christine Olungu (Data Manager) , EORTC Headquarters, Brussels
Miriam Presas (Junior RAM) , 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 Quality of Life Group
EORTC Soft Tissue and Bone Sarcoma Group
EORTC Cancer in Elderly Task Force
Recruiting centers Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
Bank Of Cyprus Oncology Centre (Strovolos - Nicosia, Cyprus)
Erasmus MC (Rotterdam, Netherlands)
Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
Hospital Universitario Fundacion Jimenez Diaz (Madrid, Spain)
Hospital Universitario General de Villalba (Collado Villalba Madrid, Spain)
Hospital Universitario Infanta Elena (Valdemoro Madrid, Spain)
Hospital Universitario Ramon y Cajal (Madrid, Spain)
Hospital Universitario Rey Juan Carlos (Mostoles Madrid, Spain)
Hospital Universitario San Carlos (Madrid, Spain)
King Hussein Cancer Center (Amman, Jordan)
Leiden University Medical Centre (Leiden, Netherlands)
Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
University College Hospital (London, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
Centers to be activated Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany)
Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom)
Hospital Universitario Puerta De Hierro (Majadahonda, Spain)
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital (Cottingham, United Kingdom)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
IRCCS - Fondazione Piemonte Inst di Candiolo (Candiolo (Torino), Italy)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary (Leicester, United Kingdom)
Protocol summary
NCT number NCT04780464
EudraCT 2021-000125-27
Financial Support EORTC Group
Rising Tide Foundation for Clinical Cancer Research