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

June 22, 2011 updated by: Tata Memorial Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital
        • Principal Investigator:
          • Manish G Agarwal, M.S(Orth)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide
Drug: Standard chemotherapy
Adriamycin + Cisplatinum and Ifosfamide
Other Names:
  • Holoxan
  • Doxorubicin
Experimental: B
zoledronic acid prior to standard chemotherapy
Drug: Standard chemotherapy
Adriamycin + Cisplatinum and Ifosfamide
Other Names:
  • Holoxan
  • Doxorubicin
Drug: Zoledronic acid
4mg IV 3 weekly for 6 doses
Other Names:
  • Zometa
  • Zolendron,
Experimental: C
zoledronic acid alone 4mg IV 3 weekly for 6 doses
Drug: Zoledronic acid
4mg IV 3 weekly for 6 doses
Other Names:
  • Zometa
  • Zolendron,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
histological response disease free interval
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Investigators

  • Principal Investigator: Manish Agarwal, M.S(Orth), Tata Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 382

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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