Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The Sutent® Observational Study is being proposed to assess the real-world usage patterns and effectiveness and tolerability of treatment of Indian patients with advanced renal cell cancer with Sutent®. Generation of such information is expected to aid everyday clinical decision-making by Indian doctors and will add to the body of generalizable evidence.
详细描述
The assignment of the patient to Sutent® treatment is not decided in advance by this noninterventional study protocol, but falls within current practice. The decision to prescribe Sutent® is clearly not driven by the decision to include the patient in this study.The sample size for this study is not based on statistical considerations. It is expected that a minimum of 100 patients will be enrolled in the study by the end of the first year and the data collected would be adequate to fulfill the observational objectives of the study.The study will be initiated at 10 sites across India during the 1st year. The study may be expanded with the addition of new sites during the 2nd year.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced renal cell cancer
- •Treatment naïve or cytokine refractory
排除标准
- •Patients presenting with a known hypersensitivity to Sunitinib or its metabolites
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)
PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.
次要结局
- Percentage of Participants With Objective Response (OR)(Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose))
- Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events(Baseline up to 1 year from start of first dose)
- Number of Participants Who Required Management of Other Adverse Events(Baseline up to 1 year from start of first dose)