Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

Phase 1

Not yet recruiting

• Conditions: Urothelial Carcinoma Ureter; Urothelial Cancer of Renal Pelvis
• Interventions: Drug: Mitomycin C

• Registration Number: NCT05979909
• Lead Sponsor: McMaster University

Brief Summary

The objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07
• Study Start: 2023-09
• Primary Completion: 2025-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Suspected upper tract urothelial carcinoma (UTUC)
• Diagnostic ureteroscopy required
• Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy

Exclusion Criteria

• Prior or concomitant urothelial carcinoma of the bladder
• History of UTUC
• Ureteroscopy within the preceding six months
• Untreated urinary tract infection
• Suspected or confirmed perforation of the upper or lower urinary tract
• Lower urinary tract fistula
• Leukopenia or thrombocytopenia
• ECOG performance status 2 or greater
• Known hypersensitivity to mitomycin C
• Pregnancy or breastfeeding
• Lack of capacity to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravesical mitomycin C (MMC)	Mitomycin C	-

Primary Outcome Measures

Name	Time	Method
Retention rate	2 years	Proportion of randomized patients who complete follow-up
Recruitment rate	30 days	Proportion of patients who consent to participate in the study after being invited to do so
Randomization rate	30 days	Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms

Secondary Outcome Measures

Name	Time	Method
Intravesical recurrence	2 years	Cumulative incidence of urothelial carcinoma of the bladder
Adverse events (any)	30 days	Cumulative incidence of adverse events
Adverse events (severe)	30 days	Cumulative incidence of grade 3-5 adverse events