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

Phase 3
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

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

Inclusion Criteria:

- Primary papillary bladder cancer at high risk for further recurrence as defined as

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

- 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

- 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

- 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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

bladder cancer recurrence rate

Outcome Description:

any bladder cancer recurrence at 2 years.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Peter J. Boström, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Turku University Hospital


Finland: Finnish Medicines Agency

Study ID:

FinnBladder 9



Start Date:

December 2012

Completion Date:

December 2017

Related Keywords:

  • Bladder Cancer
  • bladder cancer
  • recurrence
  • photodynamic diagnosis
  • PDD
  • cost analysis
  • Urinary Bladder Neoplasms