Treatment of Ta Bladder Cancer in High Risk of Recurrence - Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- bladder cancer recurrence rate
研究概览
简要总结
Bladder cancer (BC), the second most common urological malignancy, is an important public health issue. One of the main challenges in the treatment of bladder cancer if the prevention of recurrences of non-invasive tumors, which is also associated with significant costs.
The current study will investigate optimal treatment of patients with bladder cancer with high risk of tumor recurrence but low risk of progression. The main interest is comparison of photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary papillary bladder cancer at high risk for further recurrence as defined as follows:
- •Number of primary tumors ≥2, OR Size of solitary primary tumor ≥ 3 cm, OR Recurrent papillary tumors
- •Histologically proven Ta bladder cancer
- •Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder cancer
- •Written informed consent is required from every eligible patient
排除标准
- •Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading system)
- •CIS (carcinoma in situ)
- •Suspicion or evidence of papillary tumors or CIS of the upper urinary tract
- •Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer
- •Suspicion or previous history of the patient not tolerating intravesical instillations
- •Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®)
- •Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may compromise study participation (as judged by treating physician)
- •Pregnancy or lactating patient
- •Other non-cured malignancy (excepting skin basalioma or cancer in situ of the cervix uteri or any other malignancy in remission ≥5 years)
- •Age < 18 years
- •Expected survival time less than one year
- •Expected poor compliance (e.g. some severe psychiatric disorders, antisocial behaviour, or dementia)
研究组 & 干预措施
Group D
Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
干预措施: optimized MMC (Drug)
Group B
Blue light TUR-BT with no adjuvant instillations
干预措施: blue light TUR-BT (Procedure)
Group B
Blue light TUR-BT with no adjuvant instillations
干预措施: single immediate chemotherapy instillation (Drug)
Group A
White light TUR-BT with no adjuvant instillations
干预措施: white light TUR-BT (Procedure)
Group A
White light TUR-BT with no adjuvant instillations
干预措施: single immediate chemotherapy instillation (Drug)
Group C
White light TUR-BT with six weekly optimized mitomycin-C instillations.
干预措施: optimized MMC (Drug)
Group C
White light TUR-BT with six weekly optimized mitomycin-C instillations.
干预措施: single immediate chemotherapy instillation (Drug)
Group D
Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
干预措施: blue light TUR-BT (Procedure)
Group D
Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
干预措施: single immediate chemotherapy instillation (Drug)
结局指标
主要结局
bladder cancer recurrence rate
时间窗: 2 years
any bladder cancer recurrence at 2 years.
次要结局
- Treatment failure(2 years)
- Bladder cancer progression(2 years)
- mortality(2 years)
研究者
Peter Boström
MD, PhD
Turku University Hospital