Clinical trial NCT01675219: Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)
Official title: Treatment of Ta Bladder Cancer in High Risk of Recurrence - Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: bladder cancer
recurrence
photodynamic diagnosis
PDD
cost analysis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Finnbladder
First posted: 2012-08-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: bladder cancer recurrence rate
timeFrame: 2 years
Secondary outcomes:
measure: Bladder cancer progression
timeFrame: 2 years
measure: Treatment failure
timeFrame: 2 years
measure: mortality
timeFrame: 2 years
Other outcomes:
measure: costs
timeFrame: 2 years
Locations:
city: Helsinki
country: Finland
facility: HYKS Peijas Hospital
city: Hyvinkää
country: Finland
facility: Hyvinkää District Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Mikkeli
country: Finland
facility: Mikkeli Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Pori
country: Finland
facility: Satakunnan keskussairaala
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Tampere
country: Finland
facility: Hatanpään sairaala
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Peter J. Boström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hyvinkää District Hospital
name: Eero Kaasinen, Md, PhD
role: STUDY_DIRECTOR
References: