Cost Effectiveness Of Sunitinib In Central America And Caribbean

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-02-28

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

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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.

Conditions

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Metastatic Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Central America and Caribbean

Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad \& Tobago

Sunitinib

Intervention Type DRUG

Treatment for mRCC as indication approved and physician criterium

Interventions

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Sunitinib

Treatment for mRCC as indication approved and physician criterium

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No