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NCT Number: NCT05979909

Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

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.

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Key information

Conditions

Urothelial Carcinoma Ureter Urothelial Cancer of Renal Pelvis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 30 days

    Proportion of patients who consent to participate in the study after being invited to do so

  2. Randomization rate

    Time frame: 30 days

    Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms

  3. Retention rate

    Time frame: 2 years

    Proportion of randomized patients who complete follow-up

Secondary outcomes

  1. Adverse events (any)

    Time frame: 30 days

    Cumulative incidence of adverse events

  2. Adverse events (severe)

    Time frame: 30 days

    Cumulative incidence of grade 3-5 adverse events

  3. Intravesical recurrence

    Time frame: 2 years

    Cumulative incidence of urothelial carcinoma of the bladder

Study contacts

Contact information is provided by the study sponsor or research team.

Piotr Zareba, MD MPH

CONTACT

[email protected]

(905) 521-2100 ext. 47109

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Aug 7, 2023
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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