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Trial Title:
Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
NCT ID:
NCT05979909
Condition:
Urothelial Carcinoma Ureter
Urothelial Cancer of Renal Pelvis
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Mitomycins
Mitomycin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mitomycin C
Description:
Mitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley
catheter, which will be clamped for two hours.
Arm group label:
Intravesical mitomycin C (MMC)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2023
Completion date:
September 2027
Lead sponsor:
Agency:
McMaster University
Agency class:
Other
Source:
McMaster University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05979909
