Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomised phase II trial in patients with high risk GCT.

Primary objective:

• Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of 'high risk' GCT as compared to standard care

Secondary objectives:

• Determine the relapse free survival

• Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Signed written informed consent

• Male or female > 18 years of age

• Histologically proven GCT treated with surgery

• High risk GCT defined as minimal one or more of the following:

• Recurrent GCT

• GCT located in the pelvis, sacrum, spine, distal ulna or growth in soft tissue

• GCT grade III

• Pathological fracture in GCT

• Absence of local adjuvant therapy (cryosurgery or phenol instillation)

• Neutrophils > 1.5x109/L, platelets > 100x109/L, and Hb > 6 mmol/l

• Bilirubin level < 1.5 x ULN

• ASAT and ALAT < 2.5 x ULN

• Adequate renal function as defined by: serum creatinine clearance > 60 cc/min

• Expected adequacy of follow-up

Exclusion Criteria:

• Unresectable or metastatic GCT and grade IV GCT

• Prior bisphosphonate usage, except preoperative treatment with zoledronic acid up to 3 months before surgery

• Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

• Known hypersensitivity reaction to any of the components of the treatment

• Pregnancy or lactating

• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent