EORTC-1976-STBSG-QLG-ETF

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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) 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	http://clinicaltrials.gov/study/NCT04780464
NCT number	NCT04780464
EudraCT	2021-000125-27
Financial Support	STBSG Rising Tide Foundation for Clinical Cancer Research FOCA (BE)