NCT00315237已完成3 期
Prospective, Randomized Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second Line Therapy Versus Best Supportive Care After a Platinum-containing Regimen, in Patients With Advanced Transitional Cell Carcinoma of Urothelial Tract
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- duration of Overall Survival after Randomization
研究概览
简要总结
The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Bladder cancer
- •Progressed after 1st line platinum-chemotherapy
- •>= 18 years old
- •Adequate hematologic, hepatic & renal function
排除标准
- •CNS disease
- •Moderate neuropathy
- •More than 1 previous chemotherapy
研究组 & 干预措施
1
Experimental
干预措施: vinflunine and best supportive care (Drug)
结局指标
主要结局
duration of Overall Survival after Randomization
时间窗: 30-March-07
次要结局
- patient benefit(30-Mar-07)
- safety(30-Mar-2007)
- response rate(throughout the study)
- time to response(upon occurrence)
- response duration(throughout the study)
- progression free survival(throughout the study)
研究者
研究点 (1)
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