NCT00691236

Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma

Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Zoledronic acid	4mg IV 3 weekly for 6 doses
DRUG	Standard chemotherapy	Adriamycin + Cisplatinum and Ifosfamide

Timeline

• Start date: 2008-05-01
• Primary completion: 2013-05-01
• Completion: 2013-08-01
• First posted: 2008-06-05
• Last updated: 2011-06-23

Locations

1 site across 1 country: India