Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Preventing Intravesical Recurrence in Patients With Urothelial Carcinoma of the Upper Urinary Tract: a Pilot Randomized Trial of a Single Prophylactic Bladder Instillation of Mitomycin C After Diagnostic Ureteroscopy

Conditions
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Urothelial Carcinoma Ureter, Urothelial Cancer of Renal Pelvis

Intervention / Treatment
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* Drug: Mitomycin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravesical mitomycin C (MMC)<br> | Drug: Mitomycin C<br>* Mitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley catheter, which will be clamped for two hours.<br>|
| No Intervention: No intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (any) | Cumulative incidence of adverse events | 30 days | 
| Adverse events (severe) | Cumulative incidence of grade 3-5 adverse events | 30 days | 
| Intravesical recurrence | Cumulative incidence of urothelial carcinoma of the bladder | 2 years |