Intravesically Heated Thermo-chemotherapy With Mitomycin-C Prior to TURBT- Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recurrence rate of Urothelial carcinoma (UC) of bladder
研究概览
简要总结
Transurethral Resection of Bladder Tumor (TURBT) is the initial treatment procedure for urinary bladder cancer. Recurrence rate during the first year ranges between 15-38% in case of low-intermediate disease. Current literature advocate using intravesical instillations of Mitomycin-C (MMC) immediately post TURBT in order to reduce the rate of recurrence.
During the last decade, heated intravesical instillations have emerged as additional players, in the treatment of recurrent disease. By most cases, the heated intravesical instillations are given either by microwave hyperthermia (synergo®) or by conductive heat bladder wall thermo-chemotherapy (BWT).
Previous reports suggest up to 59% reduction rate in recurrence following thermo-chemotherapy upon recurrent disease. These outstanding reduction results haven't convinced significant amount of urologists worldwide to use the intravesical instillation close after endoscopic resection as TURBT, probably due to the fear of MMC adverse effects in an operated area or the fear of complications due to perforated bladder. Preliminary results have suggested favourable outcome when MMC is used prior to TURBT [see publication]. To the investigators' knowledge no previous study has prospectively examined the effect of preliminary heated intravesical installation with BWT.
详细描述
Scientific hypothesis: Patients treated with preliminary intravesical installation in a timely fashion before TURBT are expected to show lower recurrence rate and better outcome then control patients.
Participants: Three hundred patients designed to undergo TURBT in the urology department at "Sheba" Medical Center at "Tel Hashomer", Israel.
Exiting the research:
- Patient is not completing the procedure due to allergic reaction or serious adverse effect during the heated intravesical instillation .
- Patient having according to pathology report muscle invasive bladder cancer (MIBC) and expects to undergo cystectomy.
Protocol steps Eligible patients give their consent to participate in the study. A preliminary grouping (for low, intermediate and high risk groups) will be initiated according to cystoscopy examination results. (this step is for administrative purpose in order to achieve equal amount of participants between groups during follow-up phase) Then participants will randomly assign, according to randomized computer software to two major arms, those who receive the heated thermo-chemo therapy and those who will not. The intravesical instillation will take place up to 6 hours prior TURBT in the following matter: The "Elmedical" system will introduce intravesically a 40mg of heated Mitomycin-C (MMC), diluted in 50cc of saline at a uniform temperature (44-44.50C). The length of the procedure - 50 minutes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 yrs.) with good performance status according to Eastern Cooperative Oncology Group (ECOG) scale, designed to TURBT and gave their consent to participate in our research.
- •All participants must have adequate blood tests (CBC, Creatinine, electrolytes and liver function tests).
排除标准
- •Concurrent other malignancy in the urinary system (e.g. upper tract UC)
- •Urothelial malignancy of the bladder other then carcinoma
- •Diffuse carcinoma in situ on preliminary cystoscopy
- •Allergy or sensitivity to MMC
- •Known urinary bladder capacity of less then 200cc
- •Concurrent complicated urinary infection
- •Autoimmune disease or patient under immunosuppressive therapy
- •presence of urethral stricture
- •Previous pelvic radiotherapy
- •Concomitant malignancy of other organ
- •Children under 18 years.
结局指标
主要结局
Recurrence rate of Urothelial carcinoma (UC) of bladder
时间窗: Two years
Reduced recurrence rate of Urothelial carcinoma (UC) of bladder among patients receiving intravesical heated installations
次要结局
未报告次要终点
研究者
Prof. Jacob Ramon
Head of Urology department
Sheba Medical Center