Clinical trial NCT01033981: Cost Effectiveness Of Sunitinib In Central America And Caribbean
Official title: Cost Effectiveness Of Sunitinib Vs IFN-Alfa Or Bevacizumab + IFN-Alfa As First-Line Treatment In MRCC In Central America And The Caribbean
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Renal Cell Carcinoma
Keywords: cost effectiveness
Sunitinib Central America and Caribbean Metastatic Renal Cell Carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of patients that present metastasis when consulting for first time
timeFrame: 9 months
measure: Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment
timeFrame: 9 months
measure: Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α
timeFrame: 9 months
measure: 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
timeFrame: 9 months
measure: Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment
timeFrame: 9 months
Secondary outcomes:
measure: Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN
timeFrame: 9 months
measure: Quality of life in patients using an approved quality questionnaire
timeFrame: 9 months
measure: Costs-benefit of each treatment
timeFrame: 9 months
measure: PFY (progression free years) with each treatment
timeFrame: 9 months
measure: LY (life years) with each treatment
timeFrame: 9 months
measure: QALYs (quality adjusted life years) with each treatment
timeFrame: 9 months
measure: ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment
timeFrame: 9 months
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: