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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Leiden University Medical Center
Sponsor:
Information provided by (Responsible Party):
J.R. Kroep, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00889590
First received: April 28, 2009
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Giant Cell Tumor of Bone
Osteoclastoma
Drug: Zoledronic acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Determine the relapse free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2008
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Zometa
No Intervention: Control
Standard care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889590

Contacts
Contact: J R Kroep, MD PhD 31-71-5263463 j.r.kroep@lumc.nl
Contact: J Ouwerkerk 31-71-5299111 ext 9649 j.ouwerkerk@lumc.nl

Locations
Belgium
University hospital Gent Not yet recruiting
Gent, Belgium, 9000
Contact: R Forsyth, MD PhD         
Sub-Investigator: R Forsyth, MD PhD         
Principal Investigator: G Sys, MD PhD         
Netherlands
Academic Medical Center, University of Amsterdam Not yet recruiting
Amsterdam, Netherlands, 1100DD
Contact: G R Schaap, MD, PhD         
Principal Investigator: G R Schaap, MD, PhD         
Groningen University Medical Center Recruiting
Groningen, Netherlands, 9700 RB
Contact: P C Jutte, MD PhD         
Principal Investigator: P C Jutte, MD PhD         
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300RC
Contact: J R Kroep, MD PhD         
Principal Investigator: J R Kroep, MD PhD         
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
  More Information

No publications provided

Responsible Party: J.R. Kroep, MD PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00889590     History of Changes
Other Study ID Numbers: P08.185
Study First Received: April 28, 2009
Last Updated: February 14, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
GCT
Bisfosfonates

Additional relevant MeSH terms:
Bone Neoplasms
Giant Cell Tumor of Bone
Giant Cell Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014