Back to resultsIntravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
Primary Purpose
Urothelial Carcinoma Ureter, Urothelial Cancer of Renal Pelvis
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Mitomycin C
Sponsored by
About this trial
This is an interventional prevention trial for Urothelial Carcinoma Ureter
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intravesical mitomycin C (MMC)
No intervention
Arm Description
Outcomes
Primary Outcome Measures
Recruitment rate
Proportion of patients who consent to participate in the study after being invited to do so
Randomization rate
Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
Retention rate
Proportion of randomized patients who complete follow-up
Secondary Outcome Measures
Adverse events (any)
Cumulative incidence of adverse events
Adverse events (severe)
Cumulative incidence of grade 3-5 adverse events
Intravesical recurrence
Cumulative incidence of urothelial carcinoma of the bladder
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979909
Brief Title
Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma Ureter, Urothelial Cancer of Renal Pelvis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravesical mitomycin C (MMC)
Arm Type
Experimental
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Intervention Description
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 Measure Information:
Title
Recruitment rate
Description
Proportion of patients who consent to participate in the study after being invited to do so
Time Frame
30 days
Title
Randomization rate
Description
Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
Time Frame
30 days
Title
Retention rate
Description
Proportion of randomized patients who complete follow-up
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Adverse events (any)
Description
Cumulative incidence of adverse events
Time Frame
30 days
Title
Adverse events (severe)
Description
Cumulative incidence of grade 3-5 adverse events
Time Frame
30 days
Title
Intravesical recurrence
Description
Cumulative incidence of urothelial carcinoma of the bladder
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Zareba, MD MPH
Phone
(905) 521-2100
Ext
47109
Email
zareba@hhsc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
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