Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

NCT ID: NCT05979909

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urothelial Carcinoma Ureter Urothelial Cancer of Renal Pelvis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intravesical mitomycin C (MMC)

Group Type EXPERIMENTAL

Mitomycin C

Intervention Type DRUG

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Piotr Zareba, MD MPH

Role: CONTACT

(905) 521-2100 ext. 47109

Other Identifiers

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14728

Identifier Type: -

Identifier Source: org_study_id

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