NCT01390519已完成不适用
Observational Study Evaluating Efficacy, Tolerability and Treatment Algorithm of Advanced Renal Cell Cancer Patients Under Afinitor Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.
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
- •Age > 18 years
- •Confirmed diagnosis of advanced renal cell cancer
- •Progression on or after one VEGF -TKI (e.g. sunitibin, sorafenib)
- •Written informed consent
排除标准
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Time to progression (TTP)
时间窗: maximum of 12 months after inclusion of the last patient
次要结局
- Quality of life (QoL)(EORTC-QLQ C30)(maximum of 12 months after inclusion of the last patient)
- Tolerability(maximum of 12 months after inclusion of the last patient)
- Treatment algorithm(at end of study)
研究者
研究点 (1)
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