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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 Recruiting
Dates Date of activation: 26-Sep-2019
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
Agnieszka Czyz (Project Manager) agnieszka.czyz (at), EORTC Headquarters, Brussels
Laura De Meulemeester (Clinical Operations Manager) laura.demeulemeester (at), EORTC Headquarters, Brussels
Giovanna Farro (Clinical Scientist) giovanna.farro (at), EORTC Headquarters, Brussels
Andre Johan (Hans) Gelderblom (Study Co-Coordinator) , Leiden University Medical Centre, Leiden
Stephanie Kromar (Regulatory Affairs Manager) stephanie.kromar (at), EORTC Headquarters, Brussels
Saskia Litiere (Statistician) saskia.litiere (at), EORTC Headquarters, Brussels
Hafida Lmalem (Data Manager) hafida.lmalem (at), EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at), EORTC Headquarters, Brussels
Rivka Noelanders (TR Scientist) rivka.noelanders (at), EORTC Headquarters, Brussels
Sarah Nuyens (Project Manager) sarah.nuyens (at), EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) sandrine.rivrain (at), EORTC Headquarters, Brussels
Lucia Senna (Clinical Operations Assistant) lucia.senna (at), EORTC Headquarters, Brussels
Ionela Stanciu (Junior Clinical Operations Manager) ionela.stanciu (at), EORTC Headquarters, Brussels
Leen Wijnen (Data Manager) leen.wijnen (at), EORTC Headquarters, Brussels
Xiao Mang Zhou (Regulatory Affairs Administrator) xiao-mang.zhou (at), 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 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)
University College Hospital (London, United Kingdom)
Vall d'Hebron Institut Oncologia (Barcelona, Spain)
Centers to be activated Centre Leon Berard (Lyon, France)
Fondazione del Piemonte per l' Oncologia - Istituto di Candiolo-IRCCS (Candiolo (Torino), Italy)
Gustave Roussy (Villejuif, France)
Herlev Hospital - University Copenhagen (Herlev, Denmark)
Institut Claudius Regaud (Toulouse, France)
Istituto Oncologico Veneto IRCCS (Padova, Italy)
Leiden University Medical Centre (Leiden, Netherlands)
Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
Royal Orthopaedics Hospital, NHS Trust (Birmingham, United Kingdom)
Protocol summary
NCT number NCT03620149
EudraCT 2018-002096-17