NCT01475266终止2 期
Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 20
- 主要终点
- The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have provided written informed consent
- •Patients who have urothelial cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2 and satisfy both of the following criteria:
- •The maximum number of tumors is
- •Each tumor diameter: ≤ 3.5 cm.
- •Age: ≥20 years old at enrollment.
- •The functions of the major organs are adequate, and the following test value criteria are satisfied:
- •Neutrophil count ≥1,500/μL
- •Platelet count ≥10×10^4/μL
- •Hemoglobin ≥10 g/dL
排除标准
- •Patients with a single, primary bladder cancer of <0.5 cm.
- •Patients with CIS lesions in the bladder or a history thereof.
- •Patients with a history of other than stage Ta, histological grade G1 or G2 disease.
- •Patients experiencing recurrence within 4 months following TURBT for prior NMIBC (duration between the last TURBT and cystoscopic confirmation of the present recurrence is within 4 months).
- •Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening
- •Patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof.
- •Patients who had been administered EO9 in the past.
- •Patients who had been administered any other investigational drug within the past 30 days.
- •Patients having a medical condition that would make it unsafe for them to undergo TURBT under general or spinal anesthesia.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
EO9 (Apaziquone)
Experimental
干预措施: EO9 (Apaziquone) (Drug)
结局指标
主要结局
The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
时间窗: 2 years
次要结局
- The safety of EO9(2 years)
- The number of recurrences per patient(2 years)
- The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer(2 years)
- The progression rate(2 years)
- The progression-free survival period(2 years)
- The recurrence-free survival period(2 years)
- The overall survival period(2 years)
研究者
研究点 (20)
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