Phase 3 N=82 Randomized Basic Science

The Bladder Instillation Comparison Study

Urinary Bladder Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT02695771 ↗

Enrolled (actual)

Serious AEs

4.9%

Results posted

Apr 2023

Primary outcome: Primary: Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 — 15; 14; 20 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Mitomycin C (Drug); Gemcitabine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Corewell Health West
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03	15; 14; 20	—
SECONDARY Freedom From Bladder Stones/Dystrophic Calcification	24; 23; 25	—

Summary

To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.

Eligibility Criteria

Inclusion Criteria

sign an informed consent for the study
be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.

Exclusion Criteria

patients unable to consent for themselves
individuals under 18 years old
pregnant women
prisoners
patients with known allergy or intolerance to the mitomycin C or Gemcitabine
any other sound medical, psychiatric and/or social reason as determined by the investigator.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02695771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.