Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

There is a high rate of intravesical (bladder) recurrence following extirpative surgery for upper tract urothelial carcinoma. There is no single established standard of care for prevention of intravesical recurrence; however, one protocol in common use involves the use of intravesical gemcitabine instilled into the bladder during surgery and prior to entry into the bladder. There are barriers to the use of gemcitabine, especially at lower volume centers. Some evidence suggests that intravesical irrigation with sterile water has equivalent efficacy to intravesical chemotherapy in prevention of

Trial Details

NCT ID
NCT04865939
Phase
PHASE3
Sponsor
University of Texas Southwestern Medical Center
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • sterile water irrigation
  • Gemcitabine
Locations (sample)
  • Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility Criteria

  • Biopsy proven UTUC with plan for excisional surgery (distal ureterectomy or nephroureterectomy) with curative intent
  • Age 18 - 90 years
  • Life expectancy \> 1 year
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior t…

For full eligibility, visit ClinicalTrials.gov.

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