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Not yet recruiting NCT05979909

Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

Phase I Interventional Urothelial Carcinoma Ureter Urothelial Cancer of Renal Pelvis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mitomycin C.
Who it may be relevant to
Registry conditions: Urothelial Carcinoma Ureter, Urothelial Cancer of Renal Pelvis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Recruitment rate [Time frame: 30 days]
  • Randomization rate [Time frame: 30 days]
  • Retention rate [Time frame: 2 years]
Secondary outcome measures (3)
  • Adverse events (any) [Time frame: 30 days]
  • Adverse events (severe) [Time frame: 30 days]
  • Intravesical recurrence [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05979909 · 14728

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗