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| Tracking Information | |||||||||
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| First Received Date † | May 27, 2008 | ||||||||
| Last Updated Date | January 15, 2009 | ||||||||
| Start Date † | May 2008 | ||||||||
| Current Primary Outcome Measures † |
histological response disease free interval [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00691236 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma | ||||||||
| Official Title † | Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma | ||||||||
| 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 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase II, Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition † | Osteosarcoma | ||||||||
| Intervention † |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 60 | ||||||||
| Estimated Completion Date | August 2012 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | India | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00691236 | ||||||||
| Responsible Party | Dr Manish Agarwal, Tata Memorial Hospital | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Tata Memorial Hospital | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Tata Memorial Hospital | ||||||||
| Verification Date | January 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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