The Bladder Instillation Comparison Study

Status:	Recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	8/18/2016
Start Date:	April 2016
End Date:	April 2019
Contact:	Susan M Engerman, BSN
Email:	susan.engerman@spectrumhealth.org
Phone:	616-267-8406

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)

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

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.

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.

We found this trial at

sites

Urologic Consultants, P.C.

Grand Rapids, Michigan 49503

Phone: 616-267-8406

from

Grand Rapids, MI