Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

NCT05979909 | Not Yet Recruiting Phase 1

• 1 other identifier: 14728
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urothelial Carcinoma Ureter; Urothelial Cancer of Renal Pelvis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Adverse events (any)

  30 days

• Adverse events (severe)

  30 days

• Intravesical recurrence

  2 years

Study Arms (2)

Intravesical mitomycin C (MMC)

EXPERIMENTAL

Drug: Mitomycin C

No intervention

NO INTERVENTION

Interventions

Mitomycin C DRUG

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

Intravesical mitomycin C (MMC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Interventions

Mitomycin

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Piotr Zareba, MD MPH

CONTACT

(905) 521-2100; zareba@hhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share