Back to resultsEvaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma (ZOL)
Primary Purpose
Osteosarcoma
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Zoledronic acid
Standard chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteosarcoma focused on measuring osteosarcoma, zoledronic acid, bisphosphonates, adjuvant to chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity
- Non Metastatic at presentation. The metastases are ruled out by a CT scan of the chest and a PET scan.
- Patients are willing and able to afford the standard chemotherapy.
Exclusion Criteria:
- Non-extremity sarcomas. (pelvis and spine)
- Age less than 18 years or greater than 65 years
- Metastatic at presentation
- Pregnant or lactating women
- Renal dysfunction in the form of elevated serum creatinine
- Dental treatment anticipated after evaluation.
- Patients who have received or are likely to receive steroids.
Sites / Locations
- Tata Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
A
B
C
Arm Description
standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide
zoledronic acid prior to standard chemotherapy
zoledronic acid alone 4mg IV 3 weekly for 6 doses
Outcomes
Primary Outcome Measures
histological response disease free interval
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00691236
Brief Title
Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
Acronym
ZOL
Official Title
Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tata Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
osteosarcoma, zoledronic acid, bisphosphonates, adjuvant to chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide
Arm Title
B
Arm Type
Experimental
Arm Description
zoledronic acid prior to standard chemotherapy
Arm Title
C
Arm Type
Experimental
Arm Description
zoledronic acid alone 4mg IV 3 weekly for 6 doses
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zolendron,, Zometa
Intervention Description
4mg IV 3 weekly for 6 doses
Intervention Type
Drug
Intervention Name(s)
Standard chemotherapy
Other Intervention Name(s)
Doxorubicin, Holoxan
Intervention Description
Adriamycin + Cisplatinum and Ifosfamide
Primary Outcome Measure Information:
Title
histological response disease free interval
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity
Non Metastatic at presentation. The metastases are ruled out by a CT scan of the chest and a PET scan.
Patients are willing and able to afford the standard chemotherapy.
Exclusion Criteria:
Non-extremity sarcomas. (pelvis and spine)
Age less than 18 years or greater than 65 years
Metastatic at presentation
Pregnant or lactating women
Renal dysfunction in the form of elevated serum creatinine
Dental treatment anticipated after evaluation.
Patients who have received or are likely to receive steroids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manish G Agarwal, M.S(Orth)
Phone
91-22-2444-7189
Email
mgagarwal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ajay Puri, M.S(Orth)
Phone
91-22-2417-7183
Email
docpuri@vsnl.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish Agarwal, M.S(Orth)
Organizational Affiliation
Tata Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish G Agarwal, M.S(Orth)
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
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