Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspected upper tract urothelial carcinoma (UTUC)
Diagnostic ureteroscopy required
Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy
Disqualifiers
Prior or concomitant urothelial carcinoma of the bladder
History of UTUC
Ureteroscopy within the preceding six months
Untreated urinary tract infection
Trial design
Design model
Parallel
Treatments tested in this trial
Mitomycin C
DrugMitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley catheter, which will be clamped for two hours.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intravesical mitomycin C (MMC)Experimental treatment 1 intervention
Group B: No interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate
Proportion of patients who consent to participate in the study after being invited to do so
Time frame
30 days2
Randomization rate
Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
Time frame
30 days3
Retention rate
Proportion of randomized patients who complete follow-up
Time frame
2 yearsSecondary outcomes
1
Adverse events (any)
Cumulative incidence of adverse events
Time frame
30 days2
Adverse events (severe)
Cumulative incidence of grade 3-5 adverse events
Time frame
30 days3
Intravesical recurrence
Cumulative incidence of urothelial carcinoma of the bladder
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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