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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Ureter Urothelial Cancer of Renal Pelvis Drug: Mitomycin C Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2027

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Intravesical mitomycin C (MMC) 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.
No Intervention: No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 30 days ]
    Proportion of patients who consent to participate in the study after being invited to do so

  2. 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

  3. Retention rate [ Time Frame: 2 years ]
    Proportion of randomized patients who complete follow-up


Secondary Outcome Measures :
  1. Adverse events (any) [ Time Frame: 30 days ]
    Cumulative incidence of adverse events

  2. Adverse events (severe) [ Time Frame: 30 days ]
    Cumulative incidence of grade 3-5 adverse events

  3. Intravesical recurrence [ Time Frame: 2 years ]
    Cumulative incidence of urothelial carcinoma of the bladder


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05979909


Contacts
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Contact: Piotr Zareba, MD MPH (905) 521-2100 ext 47109 zareba@hhsc.ca

Sponsors and Collaborators
McMaster University
More Information
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT05979909    
Other Study ID Numbers: 14728
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: August 7, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mitomycins
Mitomycin
 Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors