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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 Closed to Patient Entry
Dates Date of activation: 11-Apr-2022
Date Step1 close: 22-Sep-2023
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
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
Niels Lema (Clinical Data Expert) , EORTC Headquarters, Brussels
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
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 Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
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)
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital (Cottingham, United Kingdom)
King Hussein Cancer Center (Amman, Jordan)
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
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)
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
University College Hospital (London, United Kingdom)
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary (Leicester, United Kingdom)
University Medical Center Groningen (Groningen, Netherlands)
Protocol summary
NCT number NCT04780464
EudraCT 2021-000125-27
Financial Support STBSG
Rising Tide Foundation for Clinical Cancer Research