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

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ClinicalTrials.gov Identifier: NCT00691236
Recruitment Status : Unknown
Verified June 2011 by Tata Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : June 5, 2008
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Tata Memorial Hospital

Tracking Information
First Submitted Date  ICMJE May 27, 2008
First Posted Date  ICMJE June 5, 2008
Last Update Posted Date June 23, 2011
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
histological response disease free interval [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00691236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
Official Title  ICMJE Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteosarcoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide
    Intervention: Drug: Standard chemotherapy
  • Experimental: B
    zoledronic acid prior to standard chemotherapy
    Interventions:
    • Drug: Zoledronic acid
    • Drug: Standard chemotherapy
  • Experimental: C
    zoledronic acid alone 4mg IV 3 weekly for 6 doses
    Intervention: Drug: Zoledronic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2013
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00691236
Other Study ID Numbers  ICMJE 382
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Manish Agarwal, Tata Memorial Hospital
Study Sponsor  ICMJE Tata Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manish Agarwal, M.S(Orth) Tata Memorial Hospital
PRS Account Tata Memorial Hospital
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP