Study

EORTC-1762-STBSG

Reduced dose-density of denosumab for maintenance therapy of unresectable giant cell tumor of bone: a multicenter phase II study "REDUCE"

Study documentation Back to result

Trial Status

All trial activities ended

Dates

Date of activation: 26-Sep-2019
Date Step1 close: 30-Sep-2020

Data management at EORTC

Yes

Design

Phase 2
Not randomized / N.A.

Targeted Sample size

EORTC Groups: 100 - All Groups: 100

Treatment

Drug
Denosumab

Study Staff

  • Emanuela Palmerini (Study Coordinator), IRCCS - Istituto Ortopedico Rizzoli, Bologna
  • Laura De Meulemeester (Senior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Hans (Andre Johan) Gelderblom (Study Co-Coordinator), Leiden University Medical Centre, Leiden
  • Saskia Litiere (Statistician), EORTC Headquarters, Brussels
  • Hafida Lmalem (Imaging Officer), EORTC Headquarters, Brussels
  • Sarah Nuyens (Project Manager), EORTC Headquarters, Brussels
  • Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Ionela Stanciu (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Leen Wijnen (Data Manager), EORTC Headquarters, Brussels

Type of cancer

  • Soft Tissue and Bone Sarcoma

Participating groups

  • EORTC Soft Tissue and Bone Sarcoma Group

Recruiting centers

  • Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
  • Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
  • Hospital Universitario San Carlos (Madrid, Spain)
  • ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
  • IRCCS - Istituto Ortopedico Rizzoli (Bologna, Italy)
  • Leiden University Medical Centre (Leiden, Netherlands)
  • Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
  • University College Hospital (London, United Kingdom)

Centers to be activated

  • Centre Leon Berard (Lyon, France)
  • Gustave Roussy (VILLEJUIF CEDEX, France)
  • Herlev Hospital - University Copenhagen (Herlev, Denmark)
  • IRCCS - Fondazione Piemonte Inst di Candiolo (Candiolo (Torino), Italy)
  • IRCCS - Istituto Oncologico Veneto (Padova, Italy)
  • University Hospital Virgen del Rocio (Sevilla, Spain)

Protocol summary

http://clinicaltrials.gov/study/NCT03620149

NCT number

NCT03620149

EudraCT

2018-002096-17