NCT03658304

Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma

A Single Arm Phase II Trial of the Intraoperative Intravesical Instillation of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Mitomycin c	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.

Timeline

• Start date: 2018-12-05
• Primary completion: 2021-11-10
• Completion: 2023-10-17
• First posted: 2018-09-05
• Last updated: 2024-11-05
• Results posted: 2022-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study