The Effectiveness and Safety of Intravesical Docetaxel Instillation After Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy or Distal Ureterectomy in Upper Urinary Tract Urothelial Carcinoma: A Prospective Study
试验速览
- 阶段
- 2 期
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Recurrence in bladder
研究概览
简要总结
The investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).
详细描述
Approximately 20% to 50% of patients with upper urinary tract urothelial carcinoma (UUT-UC) experience bladder recurrence after nephroureterectomy. Although many agents have been administered for the prevention of bladder recurrence, the standard prophylactic treatment has yet to be established. A meta-analysis found that a single instillation of chemotherapy immediately after transurethral resection of bladder tumor (TURBT) significantly decreased the risk of recurrence in patients with bladder cancer. Indeed, a single early instillation of Docetaxel was found to reduce the post-TURBT bladder recurrence rate among patients with bladder cancer.
In this prospective, randomized study, the investigators evaluated the efficacy of a single, early, intravesical instillation of Docetaxel in the prevention of bladder recurrence after nephroureterectomy for UUT-UC.
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Upper urinary tract urothelial cell carcinoma
- •Hb>10g/dL, ANC >1500mm3, Platelet > 100K
- •Total bilirubin : 1.5 times lower than the normal upper limit
- •AST/ALT: 1.8 times lower than the normal upper limit
- •Alkaline phosphatase: 1.8 times lower than the normal upper limit
排除标准
- •Concomitant bladder tumor
- •Patients diagnosed with bladder cancer within the last 3 years
- •Previous history of hypersensitivity to Docetaxel
- •Neurogenic Bladder
- •Patients who received chemotherapy for cancer within the last 6 months
- •Patients with active disease not fit for this study
- •ANC <1500mm3
- •Pregnant or lactating women
- •Patients with severe hepatic dysfunction
- •patients with severe renal impairment
- •patients with hypersensitivity to mannitol, paraplatin, platinum compounds
- •Patients with complications of infection
- •Patients suspected of having infectious fever
研究组 & 干预措施
Docetaxel bladder instillation arm
After Surgery, intravesical chemotherapy with in 48 hrs (Docetaxel 75 mg diluted in 100 cc of normal saline)
干预措施: Docetaxel (Drug)
Control arm
After Surgery, intravesical chemotherapy with in 48 hrs (Placebo, 100 cc of normal saline)
干预措施: Placebo Normal saline (Drug)
结局指标
主要结局
Recurrence in bladder
时间窗: 2years
Present of bladder recurrence after intervention in follow up cystoscopy or CT scan
次要结局
- Incidence of Treatment-Emergent Adverse Events(2years)
- Overall Survival(2years)
- Time to recurrence(2years)
研究者
Ja Hyeon Ku
Professor, MD., PHD.
Seoul National University Hospital