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

Primary Purpose

Giant Cell Tumor of Bone, Osteoclastoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Giant Cell Tumor of Bone focused on measuring GCT, Bisfosfonates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital Gent
  • Academic Medical Center, University of Amsterdam
  • Groningen University Medical Center
  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Zoledronic acid

Control

Arm Description

Adjuvant zoledronic acid

Standard care

Outcomes

Primary Outcome Measures

Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care

Secondary Outcome Measures

Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT
Determine the relapse free survival

Full Information

First Posted
April 28, 2009
Last Updated
January 25, 2016
Sponsor
Leiden University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00889590
Brief Title
Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)
Acronym
HR-GCT
Official Title
Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
low recruitment with registration denosumab
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Tumor of Bone, Osteoclastoma
Keywords
GCT, Bisfosfonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic acid
Arm Type
Experimental
Arm Description
Adjuvant zoledronic acid
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zometa
Intervention Description
4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery
Primary Outcome Measure Information:
Title
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT
Time Frame
4 years
Title
Determine the relapse free survival
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J R Kroep, MD PhD
Organizational Affiliation
Leiden University Medical Center (LUMC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P D Dijkstra, MD PhD
Organizational Affiliation
LUMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
A H Taminiau, MD PhD
Organizational Affiliation
LUMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
P C Hogendoorn, MD PhD
Organizational Affiliation
LUMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
H Gelderblom, MD PhD
Organizational Affiliation
LUMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
N A Hamdy, MD PhD
Organizational Affiliation
LUMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
S E Papapoulos, MD PhD
Organizational Affiliation
LUMC
Official's Role
Study Director
Facility Information:
Facility Name
University hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Academic Medical Center, University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1100DD
Country
Netherlands
Facility Name
Groningen University Medical Center
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300RC
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31040253
Citation
Lipplaa A, Kroep JR, van der Heijden L, Jutte PC, Hogendoorn PCW, Dijkstra S, Gelderblom H. Adjuvant Zoledronic Acid in High-Risk Giant Cell Tumor of Bone: A Multicenter Randomized Phase II Trial. Oncologist. 2019 Jul;24(7):889-e421. doi: 10.1634/theoncologist.2019-0280. Epub 2019 Apr 30.
Results Reference
derived

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

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