Adjuvant zoledronic acid in ‘high risk’ Giant Cell Tumour of bone (GCT) - A randomized phase II study - - HR-GCT

Conditions: high risk Giant Cell Tumour of bone
MedDRA version: 9.1Level: LLTClassification code 10005970Term: Bone giant cell tumour benign

Registration Number: EUCTR2008-005841-50-NL

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

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 joint/soft tissue
•GCT grade III
•Pathological fracture in GCT
•absence of local adjuvant therapy
-WHO performance status 0 - 2
-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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of ‘high risk’ GCT as compared to standard care;Secondary Objective: Determine the relapse free survival.<br>Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT<br>;Primary end point(s): 2 year recurrence rate

Secondary Outcome Measures