Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)

Turku University Hospital (TYKS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Bladder Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01675219

FinnBladder 9

2012-000559-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

Group B

Experimental group

Description:

Blue light TUR-BT with no adjuvant instillations

Treatment:

Drug: single immediate chemotherapy instillation

Procedure: blue light TUR-BT

Group A

Active Comparator group

Description:

White light TUR-BT with no adjuvant instillations

Treatment:

Drug: single immediate chemotherapy instillation

Procedure: white light TUR-BT

Group C

Experimental group

Description:

White light TUR-BT with six weekly optimized mitomycin-C instillations.

Treatment:

Drug: single immediate chemotherapy instillation

Drug: optimized MMC

Group D

Experimental group

Description:

Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.

Treatment:

Drug: single immediate chemotherapy instillation

Drug: optimized MMC

Procedure: blue light TUR-BT