Intravesical Electromotive Mitomycin for High Risk Urothelial Non-muscle Invasive Bladder Cancer After Intravesical Bacillus Calmette-Guérin Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Time to first recurrence
研究概览
简要总结
Patients with urothelial high risk non-muscle invasive bladder cancer patients will be treated with intravesical electromotive drug administration/mitomycin (EMDA/MMC) after bacillus Calmette-Guerin (BCG) failure. Patients are scheduled for an initial 6 weekly treatments, a further 6 weekly treatments for non-responders and a followup 10 monthly treatments for responders. Complete response will be defined as histological disappearance of malignancy on bladder biopsy and resolution of abnormal cytological findings after treatment. Time to first recurrence, time to progression, overall survival, and disease-specific survival wil be estimated by use of the Kaplan-Meier method.
详细描述
Partecipants
Inclusion criteria:
- Patients with urothelial high risk NMIBC (high grade stage Ta, T1 and/or carcinoma in situ) after intravesical BCG failure;
- adequate bone marrow reserve;
- normal renal function;
- normal liver function;
- Karnofsky performance score of 50 to 100.
Exclusion criteria:
- non-urothelial carcinomas of the bladder;
- known allergy to MMC;
- previous or concomitant urothelial carcinoma of the upper urinary tract and urethra, or both;
- bladder capacity less than 200 mL;
- untreated urinary-tract infection;
- severe systemic infection (ie, sepsis);
- urethral strictures that would prevent endoscopic procedures and catheterisation;
- other concurrent chemotherapy, radiotherapy, and treatment with biological response modifiers;
- other malignant diseases within 5 years of start of EMDA MMC (except for adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer);
- pregnancy;
- psychological, familial, sociological, or geographical factors that would preclude study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with urothelial high risk non-muscle invasive bladder cancer (high grade stage Ta, T1 and/or carcinoma in situ) after intravesical BCG failure;
- •adequate bone marrow reserve;
- •normal renal function;
- •normal liver function;
- •Karnofsky performance score of 50 to 100;
排除标准
- •Non-urothelial carcinomas of the bladder;
- •known allergy to mitomicyn ;
- •previous or concomitant urothelial carcinoma of the upper urinary tract and urethra, or both;
- •bladder capacity less than 200 mL;
- •untreated urinary-tract infection; severe systemic infection (ie, sepsis);
- •urethral strictures that would prevent endoscopic procedures and catheterisation;
- •other concurrent chemotherapy, radiotherapy, and treatment with biological response modifiers;
- •other malignant diseases within 5 years of start of EMDA MMC (except for adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer);
- •pregnancy;
- •psychological, familial, sociological, or geographical factors that would preclude study participation.
结局指标
主要结局
Time to first recurrence
时间窗: Up to 100 monthss. Time from enrollment to first cystoscopy noting disease recurrence.
Time from enrollment to first cystoscopy noting disease recurrence.
次要结局
- Time to disease progression(Up to 100 months. Time from randomisation until the onset of muscle invasive disease)
研究者
Savino Mauro Di Stasi
ASSOCIATE PROFESSOR OF UROLOGY
University of Rome Tor Vergata