Cost Effectiveness Of Sunitinib In Central America And Caribbean

Pfizer4 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Renal Cell Carcinoma

Interventions

SunitinibDRUG

Treatment for mRCC as indication approved and physician criterium

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Panama City, Panama City, Panama

Outcomes

Primary Outcomes

Rate of patients that present metastasis when consulting for first time

Time frame: 9 months

Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment

Time frame: 9 months

Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α

Time frame: 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

Time frame: 9 months

Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment

Time frame: 9 months

Secondary Outcomes

Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN

Time frame: 9 months

Quality of life in patients using an approved quality questionnaire

Time frame: 9 months

Costs-benefit of each treatment

Time frame: 9 months

PFY (progression free years) with each treatment

Time frame: 9 months

LY (life years) with each treatment

Time frame: 9 months

QALYs (quality adjusted life years) with each treatment

Time frame: 9 months

Data from ClinicalTrials.gov

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