NCT00491114已完成2 期
Intravesical Gemcitabine Therapy in Intermediate Risk Superficial Bladder Cancer: A Phase II Study With the Marker Lesion
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 7
- 主要终点
- To evaluate the response rate
研究概览
简要总结
This is a phase II study where chemotherapy (gemcitabine) is given into the urinary bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Superficial bladder cancer
- •No prior chemotherapy
排除标准
- •Grade 3 tumors
- •Papillary tumors invading connective tissue
- •Significant urologic disease, possible interfering with intravesical therapy
结局指标
主要结局
To evaluate the response rate
次要结局
- To define the relapse free survival
- To assess toxicity profile
研究者
研究点 (7)
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