Single Preoperative Intravesical Instillation of Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer: a Prospective Randomized Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- disease-free interval and recurrence rate
研究概览
简要总结
Early single instillation of chemotherapy after TUR is recommended in the European Association of Urology Guidelines. Nevertheless, the procedure is suboptimal for patients with multiple tumors, sometimes is not tolerated and it can results in severe complications. In both laboratory and clinical studies, intravesical electromotive drug administration (EMDA) increases mitomycin-C (MMC) bladder uptake, resulting in an improved clinical efficacy in non-muscle invasive bladder cancer (NMIBC). The investigators will compare the effects of one immediate pre-TUR intravesical EMDA/MMC instillation with one immediate post-TUR intravesical passive diffusion MMC (PD/MMC) instillation and TUR alone in patients with NMIBC.
All eligible patients with primary NMIBC will be randomized into 3 groups who will undergo transurethral resection alone (TUR/alone); TUR plus single immediate postoperative instillation (immediately after TUR) of 40 mg PD/MMC with a dwell time of 60 minutes; or single immediate preoperative instillation (immediately before TUR) of 40 mg EMDA/MMC with 20 mA electric current for 30 minutes. Patients with intermediate and high risk NMIBC will undergo adjuvant intravesical therapy. The primary end points will be the recurrence rate and disease-free interval. All clinical analyses will be performed on an intent to treat basis.
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
- Single (Outcomes Assessor)
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
- 否
入选标准
- •All patients with primary histologically proven stage pTa-pT1 transitional-cell carcinoma of the bladder
排除标准
- •Previous treatments with bacillus Calmette-Guerin, mitomycin-C, or with any other intravesical cytostatic agent
- •Concomitant urothelial tumours of the upper urinary tract
- •Previous or concomitant muscle-invasive (ie, stage T2 or higher) transitional-cell carcinoma of the bladder
- •Bladder capacity less than 200 ml
- •Untreated urinary-tract infection
- •Disease of upper urinary tract
- •Previous radiotherapy to the pelvis
- •Other concurrent chemotherapy
- •Treatment with radiotherapy-response or biological-response modifiers
- •Other malignant diseases within 5 years of trial registration (except for basal-cell carcinoma)
- •Pregnancy or nursing
- •And psychological, familial or sociological factors that would preclude study participation
研究组 & 干预措施
intravesical mitomycin-C
Patients with non-muscle invasive bladder cancer who underwent one intravesical instillation of mitomycin-C immediately after transurethral resection
干预措施: Mitomycin-C 40 mg (Drug)
electromotive mitomycin-C
Patients with non-muscle invasive bladder cancer who underwent single immediate intravesical instillation of electromotive mitomycin-C immediately before transurethral resection
干预措施: Mitomycin-C 40 mg (Drug)
结局指标
主要结局
disease-free interval and recurrence rate
时间窗: recurrence assessed at 1 and 3 years from randomisation
次要结局
- disease progression and overall and specific disease mortality(progression and mortality assessed at 5 years from randomisation)
研究者
Savino M. Di Stasi
Professor
University of Rome Tor Vergata