- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00889590
Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT) (HR-GCT)
January 25, 2016 updated by: J.R. Kroep, Leiden University Medical Center
Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gent, Belgium, 9000
- University Hospital Gent
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Amsterdam, Netherlands, 1100DD
- Academic Medical Center, University of Amsterdam
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Groningen, Netherlands, 9700 RB
- Groningen University Medical Center
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Leiden, Netherlands, 2300RC
- Leiden University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
Standard care
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Experimental: Zoledronic acid
Adjuvant zoledronic acid
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4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
Time Frame: 4 years
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4 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT
Time Frame: 4 years
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4 years
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Determine the relapse free survival
Time Frame: 4 years
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4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: J R Kroep, MD PhD, Leiden University Medical Center (LUMC)
- Study Director: P D Dijkstra, MD PhD, LUMC
- Study Director: A H Taminiau, MD PhD, LUMC
- Study Director: P C Hogendoorn, MD PhD, LUMC
- Study Director: H Gelderblom, MD PhD, LUMC
- Study Director: N A Hamdy, MD PhD, LUMC
- Study Director: S E Papapoulos, MD PhD, LUMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
April 28, 2009
First Submitted That Met QC Criteria
April 28, 2009
First Posted (Estimate)
April 29, 2009
Study Record Updates
Last Update Posted (Estimate)
January 26, 2016
Last Update Submitted That Met QC Criteria
January 25, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Musculoskeletal Diseases
- Bone Diseases
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Bone Neoplasms
- Giant Cell Tumors
- Giant Cell Tumor of Bone
- Physiological Effects of Drugs
- Bone Density Conservation Agents
- Zoledronic Acid
Other Study ID Numbers
- P08.185
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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