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

Giant Cell Tumor of Bone Clinical Trial

— HR-GCT  

Official title:

Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00889590
• Other study ID #: P08.185
• Status: Terminated
• Phase: Phase 2
• First received: April 28, 2009
• Last updated: January 25, 2016
• Start date: December 2008
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Neoplasms
• Giant Cell Tumor of Bone
• Giant Cell Tumors
• Osteoclastoma

Intervention

Drug:
• Zoledronic acid
4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery

Locations

Country	Name	City	State
Belgium	University hospital Gent	Gent
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam
Netherlands	Groningen University Medical Center	Groningen
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care		4 years	No
Secondary	Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT		4 years	No
Secondary	Determine the relapse free survival		4 years	No