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Trial Title:
Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)
NCT ID:
NCT01675219
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Mitomycins
Mitomycin
Conditions: Keywords:
bladder cancer
recurrence
photodynamic diagnosis
PDD
cost analysis
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
white light TUR-BT
Description:
traditional transurethral bladder tumor resection
Arm group label:
Group A
Intervention type:
Procedure
Intervention name:
blue light TUR-BT
Description:
photodynamic transurethral bladder tumor resection
Arm group label:
Group B
Arm group label:
Group D
Intervention type:
Drug
Intervention name:
optimized MMC
Description:
six weekly optimized mitomycin-C instillations
Arm group label:
Group C
Arm group label:
Group D
Other name:
optimized mitomycin-C
Intervention type:
Drug
Intervention name:
single immediate chemotherapy instillation
Description:
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Arm group label:
Group A
Arm group label:
Group B
Arm group label:
Group C
Arm group label:
Group D
Other name:
single instillation
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
HYKS Peijas Hospital
Address:
City:
Helsinki
Country:
Finland
Facility:
Name:
Hyvinkää District Hospital
Address:
City:
Hyvinkää
Country:
Finland
Facility:
Name:
Kuopio University Hospital
Address:
City:
Kuopio
Country:
Finland
Facility:
Name:
Mikkeli Central Hospital
Address:
City:
Mikkeli
Country:
Finland
Facility:
Name:
Oulu University Hospital
Address:
City:
Oulu
Country:
Finland
Facility:
Name:
Satakunnan keskussairaala
Address:
City:
Pori
Country:
Finland
Facility:
Name:
Seinäjoki Central Hospital
Address:
City:
Seinäjoki
Country:
Finland
Facility:
Name:
Hatanpään sairaala
Address:
City:
Tampere
Country:
Finland
Facility:
Name:
Tampere University Hospital
Address:
City:
Tampere
Country:
Finland
Facility:
Name:
Turku University Hospital
Address:
City:
Turku
Country:
Finland
Start date:
December 2012
Completion date:
August 2023
Lead sponsor:
Agency:
Turku University Hospital
Agency class:
Other
Collaborator:
Agency:
Finnbladder
Agency class:
Other
Source:
Turku University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01675219
