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See termination reason in detailed description.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Central America and Caribbean | Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad & Tobago |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | Treatment for mRCC as indication approved and physician criterium |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Panama City | Panama City | Panama |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Costs-benefit of each treatment |
| 9 months |
| PFY (progression free years) with each treatment | 9 months |
| LY (life years) with each treatment | 9 months |
| QALYs (quality adjusted life years) with each treatment | 9 months |
| ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment | 9 months |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |