OsteosarcomaPhase 2/3ZOLNCT00691236
Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
A Phase 2/3 study testing Zoledronic acid and Standard chemotherapy in people with Osteosarcoma, run by Tata Memorial Hospital at 1 site in India.
Trial summary
This trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma. In arm A of the study, 40 adult patients will be randomised into two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Zoledronic acid and Standard chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- May 2008to Aug 2013
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity
- Non Metastatic at presentation. The metastases are ruled out by a CT scan of the chest and a PET scan.
- Patients are willing and able to afford the standard chemotherapy.
Who cannot join
- Non-extremity sarcomas. (pelvis and spine)
- Age less than 18 years or greater than 65 years
- Metastatic at presentation
- Pregnant or lactating women
- Renal dysfunction in the form of elevated serum creatinine
- Dental treatment anticipated after evaluation.
- Patients who have received or are likely to receive steroids.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Manish G Agarwal, M.S(Orth)
About this study
Official title: Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma
This trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma. In arm A of the study, 40 adult patients will be randomised into two groups. One group will get standard chemotherapy and the other group will get Zoledronic acid in addition to chemotherapy. The investigators will assess the histological necrosis as well as disease status for up to 2 years.
In Arm B, adult patients with relapsed disease or advanced disease who are unable to take any other therapy and are given only symptomatic care will be given 6 doses of zoledronic acid and followed up for disease status. This will be to determine the role of zoledronic acid as a single agent.
- Conditions
- Osteosarcoma
- Being tested
- Zoledronic acid, Standard chemotherapy
- Keywords
- osteosarcoma, zoledronic acid, bisphosphonates, adjuvant to chemotherapy
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Also called Zolendron,, Zometa
4mg IV 3 weekly for 6 doses
Standard chemotherapyDrug
Also called Doxorubicin, Holoxan
Adriamycin + Cisplatinum and Ifosfamide
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide Receives: Drug: Standard chemotherapy |
| B | Experimental | zoledronic acid prior to standard chemotherapy Receives: Drug: Zoledronic acid; Drug: Standard chemotherapy |
| C | Experimental | zoledronic acid alone 4mg IV 3 weekly for 6 doses Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological response disease free interval
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Investigators
- Manish Agarwal, M.S(Orth), Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691236
- Sponsor's protocol ID
- 382
- Acronym
- ZOL
- Status last verified
- Jun 2011
- First submitted
- 27 May 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma
- ClinicalTrials.gov ID
- NCT00691236
- Acronym / sponsor ID
- ZOL / 382
- Conditions
- Osteosarcoma
- Keywords
- osteosarcoma, zoledronic acid, bisphosphonates, adjuvant to chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- May 2008
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 5 Jun 2008 (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 trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma. In arm A of the study, 40 adult patients will be randomised into two groups. One group will get standard chemotherapy and the other group will get Zoledronic acid in addition to chemotherapy. The investigators will assess the histological necrosis as well as disease status for up to 2 years.
In Arm B, adult patients with relapsed disease or advanced disease who are unable to take any other therapy and are given only symptomatic care will be given 6 doses of zoledronic acid and followed up for disease status. This will be to determine the role of zoledronic acid as a single agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Standard chemotherapystandard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide |
| B | Experimental | Drug: Zoledronic acid, Drug: Standard chemotherapyzoledronic acid prior to standard chemotherapy |
| C | Experimental | Drug: Zoledronic acidzoledronic acid alone 4mg IV 3 weekly for 6 doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity
- Non Metastatic at presentation. The metastases are ruled out by a CT scan of the chest and a PET scan.
- Patients are willing and able to afford the standard chemotherapy.
Key exclusion criteria (7 listed)
- Non-extremity sarcomas. (pelvis and spine)
- Age less than 18 years or greater than 65 years
- Metastatic at presentation
- Pregnant or lactating women
- Renal dysfunction in the form of elevated serum creatinine
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: Zolendron,, Zometa4mg IV 3 weekly for 6 doses | Drug | B, C |
| Standard chemotherapyAlso: Doxorubicin, HoloxanAdriamycin + Cisplatinum and Ifosfamide | Drug | A, B |
Primary outcome
histological response disease free interval
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
Manish Agarwal, M.S(Orth) principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zoledronic acid and Standard chemotherapy in people with Osteosarcoma, run by Tata Memorial Hospital at 1 site in India.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manish G Agarwal, M.S(Orth) (91-22-2444-7189, mgagarwal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histological response disease free interval (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2011.