Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)
NCT ID: NCT01675219
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2012-12-31
2023-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Group B
Blue light TUR-BT with no adjuvant instillations
blue light TUR-BT
photodynamic transurethral bladder tumor resection
single immediate chemotherapy instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Group A
White light TUR-BT with no adjuvant instillations
white light TUR-BT
traditional transurethral bladder tumor resection
single immediate chemotherapy instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Group C
White light TUR-BT with six weekly optimized mitomycin-C instillations.
optimized MMC
six weekly optimized mitomycin-C instillations
single immediate chemotherapy instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Group D
Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
blue light TUR-BT
photodynamic transurethral bladder tumor resection
optimized MMC
six weekly optimized mitomycin-C instillations
single immediate chemotherapy instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Interventions
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white light TUR-BT
traditional transurethral bladder tumor resection
blue light TUR-BT
photodynamic transurethral bladder tumor resection
optimized MMC
six weekly optimized mitomycin-C instillations
single immediate chemotherapy instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
100 Years
ALL
No
Sponsors
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Finnbladder
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Peter Boström
MD, PhD
Principal Investigators
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Peter J. Boström, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Eero Kaasinen, Md, PhD
Role: STUDY_DIRECTOR
Hyvinkää District Hospital
Locations
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HYKS Peijas Hospital
Helsinki, , Finland
Hyvinkää District Hospital
Hyvinkää, , Finland
Kuopio University Hospital
Kuopio, , Finland
Mikkeli Central Hospital
Mikkeli, , Finland
Oulu University Hospital
Oulu, , Finland
Satakunnan keskussairaala
Pori, , Finland
Seinäjoki Central Hospital
Seinäjoki, , Finland
Hatanpään sairaala
Tampere, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Countries
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References
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Sell V, Ettala O, Perez IM, Jarvinen R, Pekkarinen T, Vaarala M, Seppanen M, Liukkonen T, Marttila T, Aaltomaa S, Bostrom PJ. Awareness of Smoking as a Risk Factor in Bladder Cancer: Results from the Prospective FinnBladder 9 Trial. Eur Urol Focus. 2022 Sep;8(5):1246-1252. doi: 10.1016/j.euf.2022.01.012. Epub 2022 Jan 31.
Other Identifiers
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2012-000559-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FinnBladder 9
Identifier Type: -
Identifier Source: org_study_id
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