Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,840
- 主要终点
- Tumor status
研究概览
简要总结
Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.
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
- •Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib
排除标准
- •Exclusion criteria must be read in conjunction with the local product information
研究组 & 干预措施
Group 1
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
结局指标
主要结局
Tumor status
时间窗: After about 3, 6, 9 and 12 months
次要结局
- Treatment duration(At end of study after about 12 months)
- Safety of sorafenib treatment(At every documented visit for about 12 months)
- Progression-free survival(Calculation at end of study after about 12 months)
- Status of Metastases(After about 3, 6, 9 and 12 months)
- Performance status (ECOG)(After about 3, 6, 9 and 12 months)
