NCT00127595终止2 期
A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
研究概览
简要总结
This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transitional cell carcinoma
- •Histologically-proven
- •Locally advanced unresectable or metastatic
- •With at least one measurable target
- •Informed consent signed
排除标准
- •Previous chemotherapy
- •Previous radiotherapy
- •Performance status >=2
- •Peripheral neuropathy >=1
结局指标
主要结局
response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
次要结局
- overall survival
- disease free survival
- toxicity
研究者
研究点 (2)
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