Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
18 Years
N/A
Both
Giant Cell Tumor of Bone, Osteoclastoma
Trial Information
Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
GCT is a potentially malignant tumour that presents with a locally destructive osteolytic
lesion. The high risk GCT are characterized by a high recurrence rate around the 40-45%.
Zoledronic acid is a potent inhibitor of osteolysis and is capable of inducing osteoclast
and stromal cell apoptosis, which makes it an attractive adjuvant treatment in 'high risk'
GCT in order to improve clinical outcomes and reduce the recurrence rate.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
J R Kroep, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Leiden University Medical Center (LUMC)
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
P08.185
NCT ID:
NCT00889590
Start Date:
December 2008
Completion Date:
January 2015
Related Keywords:
- Giant Cell Tumor of Bone
- Osteoclastoma
- GCT
- Bisfosfonates
- Bone Neoplasms
- Giant Cell Tumors
- Giant Cell Tumor of Bone
Name | Location |
|---|
