Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma

Conditions
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Osteosarcoma

Intervention / Treatment
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* Drug: Zoledronic acid
* Drug: Standard chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>standard chemotherapy which is Adriamycin, Cisplatinum and Ifosfamide | Drug: Standard chemotherapy<br>* Adriamycin + Cisplatinum and Ifosfamide<br>* Other names: Holoxan;|
| Experimental: B<br>zoledronic acid prior to standard chemotherapy | Drug: Zoledronic acid<br>* 4mg IV 3 weekly for 6 doses<br>* Other names: Zometa;Drug: Standard chemotherapy<br>* Adriamycin + Cisplatinum and Ifosfamide<br>* Other names: Holoxan;|
| Experimental: C<br>zoledronic acid alone 4mg IV 3 weekly for 6 doses | Drug: Zoledronic acid<br>* 4mg IV 3 weekly for 6 doses<br>* Other names: Zometa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histological response disease free interval |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteosarcoma, zoledronic acid, bisphosphonates, adjuvant to chemotherapy