跳至主要内容
临床试验/CTRI/2022/02/040185
CTRI/2022/02/040185尚未招募不适用

Pilot study to evaluate safety and efficacy of single postoperative HIVEC after TURBT.

Rajiv Gandhi Cancer Institute and Research Centre1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年2月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
Incidence of adverse events

研究概览

简要总结

Carcinoma urinary bladder is most common urothelial cancer of urinary tract. Carcinoma urinary bladder is notorious for its high recurrence rates. Single dose of intravesical mitomycin in postoperative period has been recommended to reduce recurrence rate in patients of low and intermediate risk disease. The biologic rational for delivery of single postoperative dose of intravesical chemotherapy is based on the antitumor effects against tumor cells suspended in the bladder and residual tumor cells at the base of the resection bed following TURBT. Contemporary meta-analysis of randomized trials including 2278 patients reported a risk of recurrence reduction by 35% [hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.58–0.77, p < 0.001] and absolute risk reduction of 14% at 5 years. So, guideline recommendations support the use of a single postoperative intravesical dose of chemotherapy [e.g.: mitomycin C (MMC) or epirubicin] immediately after TURBT for patients with low-risk NMIBC.

Hyperthermic intravesical chemotherapy is a new technique, where mitomycin is given into urinary bladder at temperature of 41 - 43°C. Investigators reported significant improvement in disease control for high and intermediate risk disease in comparison to mitomycin.

Hyperthermic intravesical mitomycin has not been studied in postoperative setting, whereas mitomycin has been already in use in postoperative setting with proven efficacy. In view of better efficacy of HIVEC in comparison to mitomycin, we propose better oncological results with HIVEC in immediate postoperative setting.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Post-operative hyperthermic intravesical mitomycin will be given in all patients of non muscle invasive bladder cancer.

排除标准

  • Patient having:.
  • gross hematuria.
  • bladder perforation.
  • muscle invasive disease
  • Patient not willing to sign consent for the study.

结局指标

主要结局

Incidence of adverse events

时间窗: Adverse events which occur within 30 days after the study intervention.

次要结局

  • to assess Recurrence free survival, Progression free survival(Every 3 monthly.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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