Spots Global Cancer Trial Database for Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)
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Trial Identification
Brief Title: Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)
Official Title: Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
Study ID: NCT00889590
Interventions
Study Description
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 compared to standard care Secondary objectives: * Determine the relapse free survival * Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT
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 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University hospital Gent, Gent, , Belgium
Academic Medical Center, University of Amsterdam, Amsterdam, , Netherlands
Groningen University Medical Center, Groningen, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Contact Details
Name: J R Kroep, MD PhD
Affiliation: Leiden University Medical Center (LUMC)
Role: PRINCIPAL_INVESTIGATOR
Name: P D Dijkstra, MD PhD
Affiliation: LUMC
Role: STUDY_DIRECTOR
Name: A H Taminiau, MD PhD
Affiliation: LUMC
Role: STUDY_DIRECTOR
Name: P C Hogendoorn, MD PhD
Affiliation: LUMC
Role: STUDY_DIRECTOR
Name: H Gelderblom, MD PhD
Affiliation: LUMC
Role: STUDY_DIRECTOR
Name: N A Hamdy, MD PhD
Affiliation: LUMC
Role: STUDY_DIRECTOR
Name: S E Papapoulos, MD PhD
Affiliation: LUMC
Role: STUDY_DIRECTOR
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