Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

Urothelial Carcinoma Ureter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05979909
• Other study ID #: 14728
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 2023
• Est. completion date: September 2027

Study information

• Verified date: July 2023
• Source: McMaster University
• Contact: Piotr Zareba, MD MPH
• Phone: (905) 521-2100
• Email: zareba[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma Ureter

Intervention

Drug:
• Mitomycin C
Mitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley catheter, which will be clamped for two hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Proportion of patients who consent to participate in the study after being invited to do so	30 days
Primary	Randomization rate	Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms	30 days
Primary	Retention rate	Proportion of randomized patients who complete follow-up	2 years
Secondary	Adverse events (any)	Cumulative incidence of adverse events	30 days
Secondary	Adverse events (severe)	Cumulative incidence of grade 3-5 adverse events	30 days
Secondary	Intravesical recurrence	Cumulative incidence of urothelial carcinoma of the bladder	2 years