Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

McMaster University

Status and phase: Not yet enrolling; Phase 1

Conditions: Urothelial Carcinoma Ureter; Urothelial Cancer of Renal Pelvis

Treatments: Drug: Mitomycin C

Study type: Interventional

Funder types: Other

Identifiers

NCT05979909

14728

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intravesical mitomycin C (MMC)

Experimental group

Treatment:

Drug: Mitomycin C

No intervention

No Intervention group