Status:
TERMINATED
Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)
Lead Sponsor:
Leiden University Medical Center
Conditions:
Giant Cell Tumor of Bone
Osteoclastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00889590
Start Date
December 1 2008
End Date
July 1 2015
Last Update
January 26 2016
Active Locations (4)
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1
University hospital Gent
Ghent, Belgium, 9000
2
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands, 1100DD
3
Groningen University Medical Center
Groningen, Netherlands, 9700 RB
4
Leiden University Medical Center
Leiden, Netherlands, 2300RC