A Prospective, Open-label Randomized Clinical Trial of a Single Bladder Instillation of Mitomycin C vs. Gemcitabine vs. No Additional Treatment Immediately After Transurethral Resection of Bladder Tumor (TURBT)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Spectrum Health Hospitals
- Enrollment
- 101
- Locations
- 3
- Primary Endpoint
- Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03
Study Overview
Brief 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.
Detailed Description
This study will compare standard of care treatment for patients with non-muscle invasive bladder cancer (NMIBC). Patients will be randomized to one of three arms, Mitomycin C, Gemcitabine or no additional treatment immediately following TURBT in the operating suite. All treatment, surgical procedures and follow up care will be conducted according to standard of care treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Mitomycin C
Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Intervention: Mitomycin C (Drug)
Gemcitabine
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Intervention: Gemcitabine (Drug)
Outcomes
Primary Outcomes
Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03
Time Frame: Two years
The NCI CTCAE Version 4.03 grades adverse events as follows: grade 3 include severe but non-life-threatening consequences that result in hospitalization and/or interventions, including elective radiologic or operative interventions; grade 4 events include life-threatening consequences, such as those requiring urgent reoperation; and grade 5 events result in treatment-related death.
Secondary Outcomes
- Freedom From Bladder Stones/Dystrophic Calcification(Two years)
Investigators
Brian R. Lane
Urologist
Spectrum Health Hospitals