Sarcome

TITRE	Effet local du bisphosphonate sur les taux de récidive des tumeurs à cellules géantes aux épiphyses (extrémités) de l’os
PROTOCOLE ID	28229
CLINICAL TRIAL.gov ID	NCT03295981
TYPE(S) DE CANCER	Sarcome
PHASE	Phase III
TYPE D'ÉTUDE	Traitement
INSTITUTION	CENTRE UNIVERSITAIRE DE SANTE MCGILL 1001 boul. Décarie
VILLE	Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E)	Robert Turcotte
COORDONATEUR(RICE)	Mireille Dessureault mireille.dessureault@muhc.mcgill.ca 514-934-1934 poste 43022
STATUT	Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ	(EN) 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
CRITÈRES D'EXCLUSION	(EN) 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