Treatment of Ta Bladder Cancer in High Risk of Recurrence - Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)
Overview
- Phase
- Phase 3
- Intervention
- optimized MMC
- Conditions
- Bladder Cancer
- Sponsor
- Turku University Hospital
- Enrollment
- 400
- Locations
- 10
- Primary Endpoint
- bladder cancer recurrence rate
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Peter Boström
MD, PhD
Turku University Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Group D
Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
Intervention: optimized MMC
Group B
Blue light TUR-BT with no adjuvant instillations
Intervention: blue light TUR-BT
Group B
Blue light TUR-BT with no adjuvant instillations
Intervention: single immediate chemotherapy instillation
Group A
White light TUR-BT with no adjuvant instillations
Intervention: white light TUR-BT
Group A
White light TUR-BT with no adjuvant instillations
Intervention: single immediate chemotherapy instillation
Group C
White light TUR-BT with six weekly optimized mitomycin-C instillations.
Intervention: optimized MMC
Group C
White light TUR-BT with six weekly optimized mitomycin-C instillations.
Intervention: single immediate chemotherapy instillation
Group D
Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
Intervention: blue light TUR-BT
Group D
Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
Intervention: single immediate chemotherapy instillation
Outcomes
Primary Outcomes
bladder cancer recurrence rate
Time Frame: 2 years
any bladder cancer recurrence at 2 years.
Secondary Outcomes
- Treatment failure(2 years)
- Bladder cancer progression(2 years)
- mortality(2 years)