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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravesical mitomycin C (MMC) | Experimental |
| |
| No intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (any) | Cumulative incidence of adverse events | 30 days |
| Adverse events (severe) | Cumulative incidence of grade 3-5 adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Zareba, MD MPH | Contact | (905) 521-2100 | 47109 | zareba@hhsc.ca |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| 30 days |
| Intravesical recurrence | Cumulative incidence of urothelial carcinoma of the bladder | 2 years |
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |