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A Single Arm Phase II Trial of the Intraoperative Intravesical Instillation of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract
In Brief
A Phase 2 clinical trial evaluating Mitomycin c for Urothelial Carcinoma. Completed, enrolled 29 participants across 1 site.
Detailed Summary
Results of previous studies suggest that the timing of intravesical mitomycin C administration may impact bladder tumor recurrence rate following radical nephroureterectomy. This is the first study of its kind to attempt to identify the importance of timing of mitomycin C administration relative to bladder tumor recurrence rate following radical nephroureterectomy.This study will investigate the one year bladder tumor recurrence rate in patients with urothelial carcinoma of the upper urinary tract following intraoperative administration of mitomycin C during a nephroureterectomy, as well as the time to bladder tumor recurrence in this patient population.
Study Details
Timeline
Interventions
All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.