Study
EORTC-1976-STBSG-QLG-ETF
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
Trial Status
Closed to Patient Entry
Dates
Date of activation: 11-Apr-2022
Date Step1 close: 22-Sep-2023
Date Step1 close: 22-Sep-2023
Data management at EORTC
Yes
Design
Phase 3
Randomized open label
Randomized open label
Targeted Sample size
EORTC Groups: 185 - All Groups: 185
Treatment
Drug
Cyclophosphamide, Doxorubicin, Prednisolone, Prednisone
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, Y-ECI Coordinator), The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam
- Niels Lema (Clinical Data Expert), EORTC Headquarters, Brussels
- 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
NCT number
NCT04780464
