NCT01042795终止2 期
Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Disease Free Survival
研究概览
简要总结
The purpose of this study is to determine whether sutent (sunitinib)is effective in preventing tumor recurrence in patients with high risk bladder cancer who have previously had chemotherapy and cystectomy (bladder removal).
A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal. The patients are followed up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologic diagnosis of bladder carcinoma (>50% urothelial carcinoma)
- •Prior treatment with at least one cycle of platin-based neoadjuvant chemotherapy
- •Prior treatment with radical cystectomy revealing pT3NxM0 or pTanyN+M0
- •ECOG performance status of 0-1 (Appendix 2).
- •No evidence of metastases within 4 weeks of registration
- •Adequate organ and marrow function obtained within 14 days of registration
排除标准
- •Severe or uncontrolled acute or chronic medical or psychiatric condition
- •Prior antiangiogenic therapy
- •Prior pelvic radiation for bladder cancer
研究组 & 干预措施
Continuous Daily Dosing of Sunitinib
Experimental
干预措施: Sunitinib (Drug)
结局指标
主要结局
Disease Free Survival
时间窗: 2- year
2-year disease free survival
次要结局
未报告次要终点
研究者
Cheryl Lee
Associate Professor of Urology
University of Michigan
研究点 (1)
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