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

Sponsor
Leiden University Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00889590
Collaborator
(none)
15
Enrollment
4
Locations
2
Arms
78.9
Duration (Months)
3.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Zoledronic acid
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Zoledronic acid

Adjuvant zoledronic acid

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

    		•
    No Intervention: Control

    Standard care

    Outcome Measures

    Primary Outcome Measures

    1. Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care [4 years]

    Secondary Outcome Measures

    1. Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT [4 years]

    2. Determine the relapse free survival [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital Gent Gent 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

    Sponsors and Collaborators

    • Leiden University Medical Center

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    J.R. Kroep, MD PhD, Leiden University Medical Center
    ClinicalTrials.gov Identifier:
    NCT00889590
    Other Study ID Numbers:
    • P08.185
    First Posted:
    Apr 29, 2009
    Last Update Posted:
    Jan 26, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by J.R. Kroep, MD PhD, Leiden University Medical Center
    GCT
    Bisfosfonates
    Additional relevant MeSH terms:
    Giant Cell Tumors
    Bone Neoplasms
    Giant Cell Tumor of Bone
    Zoledronic Acid

    Study Results

    No Results Posted as of Jan 26, 2016