Giant Cell Tumor of BonePhase 2HR-GCTNCT00889590
Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)
A Phase 2 study testing Zoledronic acid in people with Giant Cell Tumor of Bone and Osteoclastoma, run by Leiden University Medical Center at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Tumor of Bone, Osteoclastoma
- What is being tested?
- Zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2008to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands3 sites
Academic Medical Center, University of Amsterdam
Amsterdam, 1100DD
Groningen University Medical Center
Groningen, 9700 RB
Leiden University Medical Center
Leiden, 2300RC
About this study
Official title: 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
Read the 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.
- Conditions
- Giant Cell Tumor of Bone, Osteoclastoma
- Being tested
- Zoledronic acid
- Keywords
- GCT, Bisfosfonates
- Medical subject headings
- Giant Cell Tumor of Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Also called Zometa
4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid | Experimental | Adjuvant zoledronic acid Receives: Drug: Zoledronic acid |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
Measured: 4 years
Secondary outcomes (2)
Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT
Measured: 4 years
Determine the relapse free survival
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2015
- Study completionJul 2015
Why it stopped: low recruitment with registration denosumab
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Giant Cell Tumor of BoneStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.R. Kroep, Leiden University Medical Center
- Investigators
- J R Kroep, MD PhD, Principal investigator, Leiden University Medical CenterP D Dijkstra, MD PhD, Study director, LUMCA H Taminiau, MD PhD, Study director, LUMCP C Hogendoorn, MD PhD, Study director, LUMCH Gelderblom, MD PhD, Study director, LUMCN A Hamdy, MD PhD, Study director, LUMCS E Papapoulos, MD PhD, Study director, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889590
- Sponsor's protocol ID
- P08.185
- Acronym
- HR-GCT
- Status last verified
- Jan 2016
- First submitted
- 28 Apr 2009
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31040253
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT00889590
- Acronym / sponsor ID
- HR-GCT / P08.185
- Conditions
- Giant Cell Tumor of Bone, Osteoclastoma
- Keywords
- GCT, Bisfosfonates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment with registration denosumab
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid | Experimental | Drug: Zoledronic acidAdjuvant zoledronic acid |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Neutrophils > 1.5x109/L, platelets > 100x109/L, and Hb > 6 mmol/l
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acidAlso: Zometa4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery | Drug | Zoledronic acid |
Primary outcome
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
Time frame: 4 years
2 secondary outcomes
Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT
Time frame: 4 years
Determine the relapse free survival
Time frame: 4 years
Results and safety
The study was stopped early (reason given: low recruitment with registration denosumab). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Derived from this study: PubMed 31040253Lipplaa 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.
Related trials for Giant Cell Tumor of Bone
RecruitingObservational study
Activation Sarcoma: PROMIS and Mobility Evaluation in Sarcoma Patients
Sarcoma, Giant Cell Tumor of Bone
RecruitingObservational study
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Cancer Risk, Cancer Predisposition Syndrome
RecruitingPhase 1/2
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
Adipocytic Neoplasm, Liposarcoma
RecruitingObservational study
TRACP-5b for Diagnosis and Follow-up of Giant Cell Tumor of Bone
Giant Cell Tumor of Bone, TRACP-5b
Active, not recruitingPhase 2
LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas
Bone Sarcoma, Dedifferentiated Chondrosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J R Kroep, MD PhD principal investigator
Leiden University Medical Center
P D Dijkstra, MD PhD study director
LUMC
A H Taminiau, MD PhD study director
LUMC
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic acid in people with Giant Cell Tumor of Bone and Osteoclastoma, run by Leiden University Medical Center at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low recruitment with registration denosumab). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.