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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide |
|
| B | Experimental | zoledronic acid prior to standard chemotherapy |
|
| C | Experimental | zoledronic acid alone 4mg IV 3 weekly for 6 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug | 4mg IV 3 weekly for 6 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| histological response disease free interval | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manish G Agarwal, M.S(Orth) | Contact | 91-22-2444-7189 | mgagarwal@gmail.com | |
| Ajay Puri, M.S(Orth) | Contact | 91-22-2417-7183 | docpuri@vsnl.com |
| Name | Affiliation | Role |
|---|---|---|
| Manish Agarwal, M.S(Orth) | Tata Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Memorial Hospital | Recruiting | Mumbai | Maharashtra | 400012 | India |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| D004317 | Doxorubicin |
| D007069 | Ifosfamide |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Standard chemotherapy | Drug | Adriamycin + Cisplatinum and Ifosfamide |
|
|
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D010078 | Oxazines |