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

Study documentation Back to result

Trial Status

LT-FU ongoing

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
  • 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
  • Corneel Coens (Statistician), EORTC Headquarters, Brussels
  • Laila Ben Salama (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Niels Lema (Clinical Data Expert), EORTC Headquarters, Brussels
  • Zara Nasir (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Xiao Mang Zhou (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Christine de Balincourt (Lead CRA), EORTC Headquarters, Brussels
  • Christine Bourguignon (Clinical Operations Assistant), 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)

Centers to be activated

  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany)
  • Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom)
  • Hospital Universitario Puerta De Hierro (Majadahonda, Spain)
  • 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)
  • 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)

Protocol summary

http://clinicaltrials.gov/study/NCT04780464

NCT number

NCT04780464

EudraCT

2021-000125-27