Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
ZOL
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJune 23, 2011
June 1, 2011
5 years
May 27, 2008
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
histological response disease free interval
2 years
Study Arms (3)
A
ACTIVE COMPARATORstandard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide
B
EXPERIMENTALzoledronic acid prior to standard chemotherapy
C
EXPERIMENTALzoledronic acid alone 4mg IV 3 weekly for 6 doses
Interventions
Adriamycin + Cisplatinum and Ifosfamide
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manish Agarwal, M.S(Orth)
Tata Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 27, 2008
First Posted
June 5, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2013
Study Completion
August 1, 2013
Last Updated
June 23, 2011
Record last verified: 2011-06