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

Sponsor
Tata Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00691236
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
63
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Zoledronic acid
  • Drug: Standard chemotherapy
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma
Study Start Date :
May 1, 2008
Anticipated Primary Completion Date :
May 1, 2013
Anticipated Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide

Drug: Standard chemotherapy
Adriamycin + Cisplatinum and Ifosfamide
Other Names:
  • Doxorubicin
  • Holoxan

    		•
    Experimental: B

    zoledronic acid prior to standard chemotherapy

    Drug: Zoledronic acid
    4mg IV 3 weekly for 6 doses
    Other Names:
  • Zolendron,
  • Zometa

    • Drug: Standard chemotherapy
    Adriamycin + Cisplatinum and Ifosfamide
    Other Names:
  • Doxorubicin
  • Holoxan

    		•
    Experimental: C

    zoledronic acid alone 4mg IV 3 weekly for 6 doses

    Drug: Zoledronic acid
    4mg IV 3 weekly for 6 doses
    Other Names:
  • Zolendron,
  • Zometa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. histological response disease free interval [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tata Memorial Hospital Mumbai Maharashtra India 400012

    Sponsors and Collaborators

    • Tata Memorial Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00691236
    Other Study ID Numbers:
    • 382
    First Posted:
    Jun 5, 2008
    Last Update Posted:
    Jun 23, 2011
    Last Verified:
    Jun 1, 2011
    Keywords provided by , ,
    osteosarcoma
    zoledronic acid
    bisphosphonates
    adjuvant to chemotherapy
    Additional relevant MeSH terms:
    Osteosarcoma
    Zoledronic Acid
    Doxorubicin

    Study Results

    No Results Posted as of Jun 23, 2011