NCT02074189Unknown3 期
Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer
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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 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
Effect of adjuvant chemotherapy to control tumor progression in patients after cystectomy for locally advanced bladder cancer.
详细描述
Effect of adjuvant chemotherapy based on Gemcitabine and Cisplatin to control tumor progression in patients after cystectomy for locally advanced bladder 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
- •Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
- •Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy and pelvic lymphadenectomy.
- •Transitional cell carcinoma of bladder, stage pT3N0M0.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.
- •Evidence of distant metastasis beyond the pelvis.
研究组 & 干预措施
Adjuvant Chemotherapy
Active Comparator
Adjuvant Chemotherapy(Gemcitabine, Cisplatin):Gemcitabine 1000 mg/m2 iv,D1,D8,D15;cisplatin 70 mg/m2 iv,D2.With 4 cycles. Treatment begins between 1-5 weeks after radical operation (within 42 days is recommended)
干预措施: Gemcitabine, Cisplatin (Drug)
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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