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. 2021 Dec 1;2021(12):CD013776. doi: 10.1002/14651858.CD013776.pub2

Boström 2018.

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
  • 400 participants


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
  1. No adjuvant instillations

    • Intervention: blue light TURBT with no adjuvant instillations

    • Comparator: white light TURBT with no adjuvant instillations

  2. Adjuvant instillations (6 weekly optimized mitomycin C instillations)

    • Intervention: blue light TURBT with adjuvant instillations

    • Comparator: white light TURBT with adjuvant instillations

Outcomes Primary outcomes 
  • bladder cancer recurrence at 2 years


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 
  • analysis of cost‐effectiveness

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