Cost Effectiveness Of Sunitinib In Central America And Caribbean

NCT01033981 | Terminated

• 1 other identifier: A6181189
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Renal Cell Carcinoma

Keywords

cost effectiveness; Sunitinib Central America and Caribbean Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• Rate of patients that present metastasis when consulting for first time

  9 months

• Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment

  9 months

• Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α

  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

  9 months

• Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment

  9 months

Secondary Outcomes (7)

• Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN

  9 months

• Quality of life in patients using an approved quality questionnaire

  9 months

• Costs-benefit of each treatment

  9 months

• PFY (progression free years) with each treatment

  9 months

• LY (life years) with each treatment

  9 months

Study Arms (1)

Central America and Caribbean

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

Drug: Sunitinib

Interventions

Sunitinib DRUG

Treatment for mRCC as indication approved and physician criterium

Central America and Caribbean

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Panama City, Panama City, Panama

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 17, 2009
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

PA (1)