NCT02074241Unknown不适用
Molecular Markers of Chemosensitivity for Locally Advanced, Recurrent and Metastatic Bladder Cancer Based on the Adjuvant Chemotherapy of Gemcitabine and Cisplatin-a Prospective Control Study
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- cancer progressive free survival rate
研究概览
简要总结
The purpose of this study is to try to figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.
详细描述
Figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.
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
- •Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
- •.Gone through standardize radical cystectomy and pelvic lymphadenectomy or inoperable.
- •Transitional cell carcinoma of bladder, stage pT3N0M0,T2N1M0-T3-4N1-2M1.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
- •Electrocorticography(ECOG) performance status 0-
- •Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL,
- •Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase(SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x upper limit of normal (ULN).
- •Creatinine clearance rate,Ccr ≥ 60%
- •ECG：no arrhythmias, no myocardial infarction. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.
排除标准
- •Past history of systemic chemotherapy
- •Serious heart and lung dysfunction.
- •Associated with central or peripheral neuropathy greater than 2 grade.
结局指标
主要结局
cancer progressive free survival rate
时间窗: 60 months
次要结局
- overall survival(60 months)
研究者
Zhiwen Chen
M.D,Ph.D
Southwest Hospital, China
研究点 (1)
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