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临床试验/NCT05084586
NCT05084586招募中不适用

Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation in the Early Postoperative Period of Bladder Cancer

Ankara Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Rate of Tumor Recurrence and Progression

研究概览

简要总结

In this study, the local and systemic side effects, tumor recurrens and progression rates of single or continuous epirubicin instillation during the early postoperative period were investigated in low and intermediate risk non-muscle-invasive bladder cancer.

详细描述

Bladder cancer (BC) is the seventh most commonly diagnosed cancer in the male population worldwide, while it drops to tenth when both genders are considered. Worldwide, the BC age-standardised mortality rate (per 100,000 person/years) was 3.3 for men vs. 0.86 for women.It is more common, especially in developed countries. NMIBC are divided into four groups as low-medium-high and very high risk according to EORTC (European Organization for Research and Treatment of Cancer).

Epirubicin is an anthracycline drug used for chemotherapy. Immediate single instillation of epirubicin has been shown to act by destroying circulating tumour cells after TURB(Transurethral Resection of a Bladder Tumor), and by an ablative effect on residual tumour cells at the resection site and on small overlooked tumours.European Association of Urology Guidelines on Bladder Cancer advocates single immediate postoperative intravesical chemotherapy. Early single-dose instillation of epirubicin immediately after transurethral resection was shown to improve recurrence rates in low and intermediate risk groups.

Immediate single instillation of epirubicin into the bladder can induce an array of irritative voiding symptoms including dysuria, frequency, urgency, suprapubic discomfort, hematuria and pelvic pain. In some cases, patients cannot tolerate these symptoms and may necessitate removal of chemotherapeutic agent for alleviation. Incomplete instillation leads to an increase in recurrence and progression rates. In this study, continuous infusion of epirubicin into the bladder and instillation of a single dose epirubicin will be evaluated in terms of side effects, tumor recurrence and progression rates.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Low and intermediate risk NMIBC

排除标准

  • High risk NMIBC
  • Patients who received intravesical BCG
  • Postoperative gross hematuria
  • Bladder perforation
  • Pregnancy
  • Urinary tract infection
  • Epirubicin allergy

研究组 & 干预措施

Continuous Intravesical Infusion of Epirubicin

Active Comparator

Patients who received continuous epirubicin infusion into the bladder in the early postoperative period.

干预措施: Intravesical Solution (Drug)

Single-Dose Instillation of Epirubicin

Sham Comparator

Patients who received single-dose epirubicin into the bladder in the early postoperative period.

干预措施: Intravesical Solution (Drug)

结局指标

主要结局

Rate of Tumor Recurrence and Progression

时间窗: 1 year

Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment

次要结局

未报告次要终点

研究者

发起方
Ankara Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Kaan Yildiz

Principal Investigator

Ankara Training and Research Hospital

研究点 (1)

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