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)
2 other identifiers
interventional
400
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2012
Longer than P75 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedApril 13, 2023
April 1, 2023
9 years
August 25, 2012
April 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bladder cancer recurrence rate
any bladder cancer recurrence at 2 years.
2 years
Secondary Outcomes (3)
Bladder cancer progression
2 years
Treatment failure
2 years
mortality
2 years
Other Outcomes (1)
costs
2 years
Study Arms (4)
Group B
EXPERIMENTALBlue light TUR-BT with no adjuvant instillations
Group A
ACTIVE COMPARATORWhite light TUR-BT with no adjuvant instillations
Group C
EXPERIMENTALWhite light TUR-BT with six weekly optimized mitomycin-C instillations.
Group D
EXPERIMENTALBlue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
Interventions
six weekly optimized mitomycin-C instillations
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finnbladdercollaborator
- Turku University Hospitallead
Study Sites (10)
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
Related Publications (1)
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.
PMID: 35094962DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J. Boström, MD, PhD
Turku University Hospital
- STUDY DIRECTOR
Eero Kaasinen, Md, PhD
Hyvinkää District Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 25, 2012
First Posted
August 29, 2012
Study Start
December 1, 2012
Primary Completion
December 1, 2021
Study Completion
August 1, 2023
Last Updated
April 13, 2023
Record last verified: 2023-04