Study name |
Treatment of Ta bladder cancer in high risk of recurrence—fluorescence cystoscopy with optimized adjuvant mitomycin‐C (FinnBladder 9) |
Methods |
randomized
multicenter/Finland
|
Participants |
Estimated enrollment
Study setting
primary/recurrent
only Ta
Eligibility 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 to 2 (WHO 1973 grading system) or PUNLMP or low‐grade (WHO 2004 grading system) bladder cancer
Non‐eligibility criteria
grade 3 tumors (WHO 1973 grading system) or high‐grade tumors (WHO 2004 grading system)
CIS
suspicion or evidence of papillary tumors or CIS of the upper urinary tract
non‐transitional cell carcinoma
suspicion or previous history of the patient not tolerating intravesical instillations
known allergy to mitomycin C or hexaminolevulinate
|
Interventions |
-
No adjuvant instillations
-
Adjuvant instillations (6 weekly optimized mitomycin C instillations)
|
Outcomes |
Primary outcomes
Secondary outcomes
bladder cancer progression to T2 or higher
progression, recurrence, or side effects preventing completion of the trial
treatment failure (progression, recurrence, or side effects preventing completion of the trial)
death due to bladder cancer or other reasons
Other outcomes
|
Starting date |
August 2012 |
Contact information |
Date of contact attempt to first study author: 28 June 2021 Contact status: reply by author 8 July 2021; study still recruiting; date of anticipated publication 2022 to 2023 |
Notes |
clinicaltrials.gov/ct2/show/NCT01675219
|