Status:
UNKNOWN
Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Osteosarcoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 g...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00691236
Start Date
May 1 2008
End Date
August 1 2013
Last Update
June 23 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012