EORTC-1762-STBSG

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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 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
Financial Support	Educational Grant EORTC Group