Cost Effectiveness Of Sunitinib In Central America And Caribbean

Metastatic Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01033981
• Other study ID #: A6181189
• Status: Terminated
• Phase: Phase 4
• First received: December 14, 2009
• Last updated: April 17, 2012
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Costa Rica: Centro de Desarrollo Estratégico e Información en Salud y Seguridad Social (CENDEISSS)
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• Sunitinib
Treatment for mRCC as indication approved and physician criterium

Locations

Country	Name	City	State
Panama	Pfizer Investigational Site	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients that present metastasis when consulting for first time		9 months	No
Primary	Rate of use of Sutent, IFN-a and Bevacizumab + IFN-a as first-line treatment		9 months	No
Primary	Hospitalization average with Sutent, with IFN-a, and with Bevacizumab + IFN-a		9 months	No
Primary	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		9 months	No
Primary	Average number of cycles of Sutent, IFN-a and Bevacizumab + IFN in first-line treatment		9 months	No
Secondary	Percentage of adverse effects with the use of Sunitinib, IFN-a and Bevacizumab + IFN		9 months	No
Secondary	Quality of life in patients using an approved quality questionnaire		9 months	No
Secondary	Costs-benefit of each treatment		9 months	No
Secondary	PFY (progression free years) with each treatment		9 months	No
Secondary	LY (life years) with each treatment		9 months	No
Secondary	QALYs (quality adjusted life years) with each treatment		9 months	No
Secondary	ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment		9 months	No

External Links

•   To obtain contact information for a study center near you, click here.