Cost Effectiveness Of Sunitinib Vs IFN-Alfa Or Bevacizumab + IFN-Alfa As First-Line Treatment In MRCC In Central America And The Caribbean
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Rate of patients that present metastasis when consulting for first time
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Central America and Caribbean
Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad & Tobago
干预措施: Sunitinib (Drug)
结局指标
主要结局
Rate of patients that present metastasis when consulting for first time
时间窗: 9 months
Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment
时间窗: 9 months
Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α
时间窗: 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
时间窗: 9 months
Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment
时间窗: 9 months
次要结局
- 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)
- QALYs (quality adjusted life years) with each treatment(9 months)
- ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment(9 months)