Preventing Intravesical Recurrence in Patients With Urothelial Carcinoma of the Upper Urinary Tract: a Pilot Randomized Trial of a Single Prophylactic Bladder Instillation of Mitomycin C After Diagnostic Ureteroscopy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Randomization rate
研究概览
简要总结
The objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Suspected upper tract urothelial carcinoma (UTUC)
- •Diagnostic ureteroscopy required
- •Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy
排除标准
- •Prior or concomitant urothelial carcinoma of the bladder
- •History of UTUC
- •Ureteroscopy within the preceding six months
- •Untreated urinary tract infection
- •Suspected or confirmed perforation of the upper or lower urinary tract
- •Lower urinary tract fistula
- •Leukopenia or thrombocytopenia
- •ECOG performance status 2 or greater
- •Known hypersensitivity to mitomycin C
- •Pregnancy or breastfeeding
- •Lack of capacity to consent
研究组 & 干预措施
Intravesical mitomycin C (MMC)
干预措施: Mitomycin C (Drug)
结局指标
主要结局
Randomization rate
时间窗: 30 days
Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
Recruitment rate
时间窗: 30 days
Proportion of patients who consent to participate in the study after being invited to do so
Retention rate
时间窗: 2 years
Proportion of randomized patients who complete follow-up
次要结局
- Adverse events (any)(30 days)
- Adverse events (severe)(30 days)
- Intravesical recurrence(2 years)