Status:

NOT_YET_RECRUITING

Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

Lead Sponsor:

McMaster University

Conditions:

Urothelial Carcinoma Ureter

Urothelial Cancer of Renal Pelvis

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 dia...

Eligibility Criteria

Inclusion

  • Suspected upper tract urothelial carcinoma (UTUC)
  • Diagnostic ureteroscopy required
  • Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT05979909

Start Date

September 1 2023

End Date

September 1 2027

Last Update

August 7 2023

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