Treatment of Ta Bladder Cancer in High Risk of Recurrence – Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)

Condition: Bladder Cancer

Intervention:

• Procedure: white light TUR-BT
• Procedure: blue light TUR-BT
• Drug: optimized MMC
• Drug: single immediate chemotherapy instillation

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01675219

Sponsor: Turku University Hospital

Primary Outcome Measures:

• Measure: bladder cancer recurrence rate
• Time Frame: 2 years
• Safety Issue:

Secondary Outcome Measures:

• Measure: Bladder cancer progression
• Time Frame: 2 years
• Safety Issue:
• Measure: Treatment failure
• Time Frame: 2 years
• Safety Issue:
• Measure: mortality
• Time Frame: 2 years
• Safety Issue:

Estimated Enrollment: 400

Study Start Date: December 2012

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum 100 Years
• Gender: All

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
• Expected survival time less than one year
• Expected poor compliance (e.g. some severe psychiatric disorders, antisocial behaviour, or dementia)

Contact:

• Peter J Boström, MD, PhD
• +358 2 313035925

Locations:

• HYKS Peijas Hospital
• Helsinki Finland

• Hyvinkää District Hospital
• Hyvinkää Finland

• Kuopio University Hospital
• Kuopio Finland

• Mikkeli Central Hospital
• Mikkeli Finland

• Oulu University Hospital
• Oulu Finland

• Satakunnan keskussairaala
• Pori Finland

• Seinäjoki Central Hospital
• Seinäjoki Finland

• Hatanpään sairaala
• Tampere Finland

• Tampere University Hospital
• Tampere Finland

• Turku University Hospital
• Turku Finland

View trial on ClinicalTrials.gov