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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01033981 |
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Date of registration:
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14/12/2009 |
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Primary sponsor: |
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Public title:
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Cost Effectiveness Of Sunitinib In Central America And Caribbean
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Scientific 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 |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01033981 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Dominican Republic
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Honduras
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Panama
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion 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-a 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-a or Bevacizumab + IFN.
- Adult men or women with mRCC with palliative care.
- Adult men or women with RCC without metastasis.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Renal Cell Carcinoma
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Intervention(s)
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Drug: Sunitinib
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Primary Outcome(s)
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Average number of cycles of Sutent, IFN-a and Bevacizumab + IFN in first-line treatment
[Time Frame: 9 months]
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Hospitalization average with Sutent, with IFN-a, and with Bevacizumab + IFN-a
[Time Frame: 9 months]
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Rate of patients that present metastasis when consulting for first time
[Time Frame: 9 months]
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Rate of success in first-line treatment with Sutent, in first-line treatment with IFN-a and in first-line treatment with Bevacizumab + IFN-a
[Time Frame: 9 months]
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Rate of use of Sutent, IFN-a and Bevacizumab + IFN-a as first-line treatment
[Time Frame: 9 months]
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Secondary Outcome(s)
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Costs-benefit of each treatment
[Time Frame: 9 months]
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ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment
[Time Frame: 9 months]
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LY (life years) with each treatment
[Time Frame: 9 months]
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Percentage of adverse effects with the use of Sunitinib, IFN-a and Bevacizumab + IFN
[Time Frame: 9 months]
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PFY (progression free years) with each treatment
[Time Frame: 9 months]
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QALYs (quality adjusted life years) with each treatment
[Time Frame: 9 months]
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Quality of life in patients using an approved quality questionnaire
[Time Frame: 9 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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