Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
Information source: Tata Memorial Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteosarcoma
Intervention: Zoledronic acid (Drug); Standard chemotherapy (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Tata Memorial Hospital Official(s) and/or principal investigator(s): Manish Agarwal, M.S(Orth), Principal Investigator, Affiliation: Tata Memorial Hospital
Overall contact: Manish G Agarwal, M.S(Orth), Phone: 91-22-2444-7189, Email: mgagarwal@gmail.com
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. 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.
Clinical Details
Official title: Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: histological response disease free interval
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high
grade osteosarcoma of the extremity
2. Non Metastatic at presentation. The metastases are ruled out by a CT scan of the
chest and a PET scan.
3. Patients are willing and able to afford the standard chemotherapy.
Exclusion Criteria:
1. Non-extremity sarcomas. (pelvis and spine)
2. Age less than 18 years or greater than 65 years
3. Metastatic at presentation
4. Pregnant or lactating women
5. Renal dysfunction in the form of elevated serum creatinine
6. Dental treatment anticipated after evaluation.
7. Patients who have received or are likely to receive steroids.
Locations and Contacts
Manish G Agarwal, M.S(Orth), Phone: 91-22-2444-7189, Email: mgagarwal@gmail.com
Tata Memorial Hospital, Mumbai, Maharashtra 400012, India; Recruiting Manish G Agarwal, M.S(Orth), Principal Investigator
Additional Information
Starting date: May 2008
Last updated: June 22, 2011
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