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

This study is currently recruiting participants.

Verified April 2012 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: April 15, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 28, 2009

Last Updated Date

April 15, 2012

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00889590 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Giant Cell Tumor of Bone
Osteoclastoma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Zoledronic acid
Adjuvant zoledronic acid

Intervention: Drug: Zoledronic acid
No Intervention: Control
Standard care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Belgium, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00889590

Other Study ID Numbers ^ICMJE

P08.185

Has Data Monitoring Committee

Responsible Party

J.R. Kroep, Leiden University Medical Center

Study Sponsor ^ICMJE

Leiden University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Leiden University Medical Center

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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