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

Study documentation

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
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
NCT number NCT03620149
EudraCT 2018-002096-17
Financial Support Educational Grant