Phase 3
Completed N=82
The Bladder Instillation Comparison Study
Source: ClinicalTrials.gov NCT02695771 ↗Enrolled (actual)
82
Serious AEs
4.9%
Results posted
Apr 2023
Primary outcomePrimary: Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 — 15; 14; 20 Participants
◆ Published Evidence
Established
39citations · ~8 / year
Intravesical gemcitabine for non-muscle invasive bladder cancer.
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.
Linked Publications
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Intravesical gemcitabine for non-muscle invasive bladder cancer.
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02695771) and the linked publication. 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. Informational only — not medical advice.