The Effects of Sequential Mitomycin and Bacillus Calmette-Guérin Treatment Versus Bacillus Calmette-Guérin Monotherapy in Patients With High Risk Non-Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 140
- 主要终点
- Recurrence rate
研究概览
简要总结
A consecutive series of patients with High Risk Non-Muscle Invasive Bladder Cancer will be enrolled in several centres. The subjects will be assessed for eligibility at the screening visit (Visit 1) three weeks after Trans-Urethral Resection of the Bladder (TURB) and re-TURB prior to randomization and only subjects who fulfil the inclusion criteria will be included. Patients selected for the study, are centrally randomized (randomization is performed at the Sant'Andrea Hospital) to receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with Immucyst (81 mg Connaught strain BCG). Patients in group two received BCG treatment with the same protocol with a 40 mg mitomycin instillation the day before .
详细描述
Methods:
A consecutive series of patients with High Risk Non-Muscle Invasive Bladder Cancer will be enrolled in several centres
Clinical evaluation:
Patients with High Risk Non-Muscle Invasive Bladder Cancer will be enrolled. For each patients we evaluate the following parameters:
- Age
- Sex
- Occupational status
- Smoker Status
- Co-morbidities
- Concomitant medications or treatment
- Height, Weight, BMI
- Urinary symptoms evaluation:
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 (Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with high risk non muscle invasive bladder cancer
- •High risk of progression (EORTC risk score > 6)
- •Signature of Informed Consent
- •Ability of consent
排除标准
- •Low Risk Non-Muscle Invasive Bladder Cancer
- •Muscle Invasive Bladder Cancer
- •Concomitant Urothelial Bladder Cancer in the Upper-Urinary Tract
- •Previous bladder or prostate surgery
- •Prostate or bladder radiotherapy
- •Urinary tract infection
- •Chronic urinary retention or indwelling catheters
- •Neurological patients
- •Previous BCG infections
- •Previous or current chemotherapy for other kind of cancers
- •Patients older than 75
- •WHO performance status 3-4
- •Residual tumour on re-TURB
研究组 & 干预措施
Mytomicin and Bacillus Calmette-Guérin
Patients received BCG treatment with the same protocol. Intervention will be a 40 mg mitomycin instillation the day before every single BCG instillation
干预措施: Mitomycin (Drug)
结局指标
主要结局
Recurrence rate
时间窗: 2 years
To evaluate the effect in term of recurrence rate of sequential combination therapy of Mitomycin and Bacillus Calmette-Guérin versus Bacillus Calmette-Guérin monotherapy in patients with High grade Non-Muscle Invasive Bladder Cancer.through cystoscopy every three months and Uro Tomography Computerized yearly
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(2 years)