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

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

INTRODUCTION

  • Org Study ID: FinnBladder 9
  • Secondary ID: 2012-000559-15
  • NTC ID: NCT01675219
  • Sponsor: Turku University Hospital

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.

  • Overall Status
    Unknown status
  • Start Date
    December 2012
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: bladder cancer recurrence rate

Primary Outcome 1 - Timeframe: 2 years

CONDITION

  • Bladder Cancer

ELIGIBILITY

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Peter J. Boström, MD, PhD, Eero Kaasinen, Md, PhD

Role: Principal Investigator, Study Director

Affiliation: Turku University Hospital, Hyvinkää District Hospital

Overall Contact

Name: Peter J. Boström, MD, PhD, Eero Kaasinen, Md, PhD

Phone: +358 2 313035925, +358 50 427 1015

Email: peter.bostrom@tyks.fi, riikka.järvinen@hus.fi

LOCATION

Facility Status Contact