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Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05979909
Recruitment Status : Not yet recruiting
First Posted : August 7, 2023
Last Update Posted : August 7, 2023
Sponsor:
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE July 31, 2023
First Posted Date  ICMJE August 7, 2023
Last Update Posted Date August 7, 2023
Estimated Study Start Date  ICMJE September 2023
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2023)
  • Recruitment rate [ Time Frame: 30 days ]
    Proportion of patients who consent to participate in the study after being invited to do so
  • Randomization rate [ Time Frame: 30 days ]
    Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
  • Retention rate [ Time Frame: 2 years ]
    Proportion of randomized patients who complete follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2023)
  • Adverse events (any) [ Time Frame: 30 days ]
    Cumulative incidence of adverse events
  • Adverse events (severe) [ Time Frame: 30 days ]
    Cumulative incidence of grade 3-5 adverse events
  • Intravesical recurrence [ Time Frame: 2 years ]
    Cumulative incidence of urothelial carcinoma of the bladder
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Urothelial Carcinoma Ureter
  • Urothelial Cancer of Renal Pelvis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intravesical mitomycin C (MMC)
    Intervention: Drug: Mitomycin C
  • No Intervention: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2023)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2027
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Piotr Zareba, MD MPH (905) 521-2100 ext 47109 zareba@hhsc.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05979909
Other Study ID Numbers  ICMJE 14728
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party McMaster University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE McMaster University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account McMaster University
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP