Groupe d'Etude en Oncologie du Quebec

Title	Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
Protocole ID	28229
ClinicalTrials.gov ID	NCT03295981
Cancer Type(s)	Sarcoma
Phase	Phase III
Stage
Study Type	Treatment
Drug	Acide Zolédronique
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL HOPITAL GENERAL DE MONTREAL 1650 Avenue Cedar, Montréal, QC, H3G 1A4
City
Principal Investigator	Dr. Robert Turcotte
Coordinator	Mireille Dessureault 514-934-1934 poste 43022
Status	Recruiting
Activation Date
Eligibility Criteria	Primary benign GCT of bone Lesion located in an extremity Lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal No previous systemic bisphosphonate or denosumab therapy Serum creatinine level less than 3.5 mg/dL Corrected total serum calcium level of 8.0 mg/dL or greater
Exclusion Criteria	Recurrent GCT of bone Non-extremity location Lesion too extensive for intralesional treatment, either due to bone loss, joint invasion, or large soft tissue component Children and pregnancy Previous systemic bisphosphonate or denosumab therapy Hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation Patients with severe renal impairment (drug excreted by the kidney) Patients with hypocalcaemia

Groupe d'étude en oncologie du Québec