Cost Effectiveness Of Sunitinib In Central America And Caribbean

Study Overview
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Brief Summary
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Primary Hypothesis: The therapy with Sunitinib represents better cost-effectiveness than IFN-α in first-line treatment for metastatic Renal Cell Carcinoma (mRCC) in Central America and Caribbean countries

Detailed Description
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This study was terminated on 03Feb2011 due to the fact that the anticipated number of patients expected was not reached. The date of cessation of the drug was January 27, 2011. There was no intervention in the treatment or administration of the drug; the study only observed the treatment and collected data. As the study was dependent on the arrival of new patients with metastatic renal cancer, which was of a very low incidence, the study was terminated. Efficacy, adverse events or other safety issues were not factors in terminating the study. Lack of patients was the only reason.

Official Title
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Cost Effectiveness Of Sunitinib Vs IFN-Alfa Or Bevacizumab + IFN-Alfa As First-Line Treatment In MRCC In Central America And The Caribbean

Conditions
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Metastatic Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of a personally signed (or legally acceptable representative) and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Adult (18 years old or older) men and women with confirmed diagnosis of mRCC treated with Sutent, IFN-α or Bevacizumab + IFN ; on the selected institutions. Exclusion Criteria: Adult men or women with RCCm treated with any other medication that is not Sutent, IFN-α or Bevacizumab + IFN. Adult men or women with mRCC with palliative care. Adult men or women with RCC without metastasis.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Central America and Caribbean<br>Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad & Tobago | Drug: Sunitinib<br>* Treatment for mRCC as indication approved and physician criterium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients that present metastasis when consulting for first time |  | 9 months | 
| Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment |  | 9 months | 
| Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α |  | 9 months | 
| Rate of success in first-line treatment with Sutent, in first-line treatment with IFN-α and in first-line treatment with Bevacizumab + IFN-α |  | 9 months | 
| Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN |  | 9 months | 
| Quality of life in patients using an approved quality questionnaire |  | 9 months | 
| Costs-benefit of each treatment |  | 9 months | 
| PFY (progression free years) with each treatment |  | 9 months | 
| LY (life years) with each treatment |  | 9 months | 
| QALYs (quality adjusted life years) with each treatment |  | 9 months | 
| ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cost effectiveness, Sunitinib Central America and Caribbean Metastatic Renal Cell Carcinoma