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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery
University hospital Gent
Ghent, Belgium
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands
Groningen University Medical Center
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
Time frame: 4 years
Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT
Time frame: 4 years
Determine the relapse free survival
Time frame: 4 years
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