PRIMARY OBJECTIVE:
I. To determine the efficacy of a single intraoperative intravesical instillation of gemcitabine hydrochloride (gemcitabine) at time of radical nephroureterectomy (RNU) for clinically localized upper tract urothelial carcinoma (UTUC) in preventing intravesical recurrence of urothelial cancer (UC) at one year.
SECONDARY OBJECTIVES:
I. To assess time to recurrence for entire duration of follow-up. II. To assess the qualitative and quantitative toxicities.
EXPLORATORY OBJECTIVES:
I. To stratify intravesical UC recurrence free survival by tumor grade, neoadjuvant chemotherapy, tumor stage, ureteral tumor location, and history of bladder cancer.
II. To assess incidence and time to development of muscle-invasive bladder cancer (MIBC).
OUTLINE:
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
After completion of study, patients are followed up at 2 weeks, and 3, 6, 12, 18, and 24 months.
