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Brief Title: The Bladder Instillation Comparison Study

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)

INTRODUCTION

  • Org Study ID: 2016-030
  • Secondary ID: N/A
  • NCT ID: NCT02695771
  • Sponsor: Spectrum Health Hospitals

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.

  • Overall Status
    Completed
  • Start Date
    April 19, 2016
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

Inclusion Criteria:
1. sign an informed consent for the study

- 2. be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.
Exclusion Criteria:
1. patients unable to consent for themselves

- 2. individuals under 18 years old

- 3. pregnant women

- 4. prisoners

- 5. patients with known allergy or intolerance to the mitomycin C or Gemcitabine

- 6. any other sound medical, psychiatric and/or social reason as determined by the investigator.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Brian R Lane, MD

Role: Principal Investigator

Affiliation: Spectrum Health Hospitals

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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