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| Sponsored by: |
Tata Memorial Hospital |
|---|---|
| Information provided by: | Tata Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00691236 |
Purpose
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. we will assess the histological necrosis as well as disease status for upto 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 | Intervention | Phase |
|---|---|---|
|
Osteosarcoma |
Drug: Zoledronic acid Drug: Zoledronic acid + standard chemotherapy Drug: Standard chemotherapy |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide
|
Drug: Standard chemotherapy
Adriamycin + Cisplatinum and Ifosfamide
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B: Experimental
zoledronic acid + standard chemotherapy
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Drug: Zoledronic acid + standard chemotherapy
Zoledronic acid 4mg IV prior to chemotherapy Standard Chemotherapy (Adriamycin + Cisplatinum and Ifosfamide)
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C: Experimental
zoledronic acid alone
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Drug: Zoledronic acid
4mg IV 3 weekly for 6 doses
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Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Manish G Agarwal, M.S(Orth) | 91-22-2417-7184 | mgagarwal@gmail.com |
| Contact: Ajay Puri, M.S(Orth) | 91-22-2417-7183 | docpuri@vsnl.com |
| India, Maharashtra | |
| Tata Memorial Hospital | Recruiting |
| Mumbai, Maharashtra, India, 400012 | |
| Principal Investigator: Manish G Agarwal, M.S(Orth) | |
| Principal Investigator: | Manish Agarwal, M.S(Orth) | Tata Memorial Hospital |
More Information
| Responsible Party: | Tata Memorial Hospital ( Dr Manish Agarwal ) |
| Study ID Numbers: | 382 |
| Study First Received: | May 27, 2008 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00691236 |
| Health Authority: | India: Ministry of Health |
|
osteosarcoma zoledronic acid bisphosphonates adjuvant to chemotherapy |
|
Neoplasms, Connective and Soft Tissue Ifosfamide Diphosphonates Zoledronic acid Cisplatin Malignant mesenchymal tumor |
Sarcoma Osteosarcoma Osteogenic sarcoma Doxorubicin Soft tissue sarcomas Isophosphamide mustard |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Bone Density Conservation Agents Neoplasms, Connective Tissue Antibiotics, Antineoplastic Pharmacologic Actions |
