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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Giant Cell Tumor of Bone Osteoclastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zoledronic acid

Adjuvant zoledronic acid

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery

Control

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Zoledronic acid

4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery

Intervention Type DRUG

Other Intervention Names

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Zometa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No