Cost Effectiveness Of Sunitinib In Central America And Caribbean

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01033981
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : December 17, 2009
Last Update Posted : April 19, 2012
Information provided by (Responsible Party):

December 14, 2009
December 17, 2009
April 19, 2012
May 2010
February 2011   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01033981 on Archive Site
  • 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 ]
  • ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment [ Time Frame: 9 months ]
Same as current
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Cost Effectiveness Of Sunitinib In Central America And Caribbean
Cost Effectiveness Of Sunitinib Vs IFN-Alfa Or Bevacizumab + IFN-Alfa As First-Line Treatment In MRCC In Central America And The Caribbean
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.
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Adult men and women with mRCC will be evaluated for entering the study. The decision to use Sunitinib, IFN-α or Bevacizumab + IFN must be a joint decision made by the subject and the investigator. The investigator must discuss product information with the subject as per usual practice.
Metastatic Renal Cell Carcinoma
Drug: Sunitinib
Treatment for mRCC as indication approved and physician criterium
Central America and Caribbean
Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad & Tobago
Intervention: Drug: Sunitinib
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2011
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Dominican Republic,   Honduras
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Study Director: Pfizer Call Center Pfizer
April 2012