Actively Recruiting
Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma
Led by University of Texas Southwestern Medical Center · Updated on 2025-07-17
132
Participants Needed
1
Research Sites
517 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 recurrent bladder cancer following transurethral resection of bladder tumors (TURBT). This study is intended to compare recurrence rates using intravesical gemcitabine (as a pseudo-standard of care) and continuous bladder irrigation with sterile water.
CONDITIONS
Official Title
Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven upper tract urothelial carcinoma with planned excisional surgery (distal ureterectomy or nephroureterectomy) with curative intent
- Age between 18 and 90 years
- Life expectancy greater than 1 year
- Women of child-bearing potential and men must agree to use effective contraception during the study and for 90 days after therapy
- Ability to understand and sign informed consent
- Definition of female of child-bearing potential includes women without hysterectomy or bilateral oophorectomy, or who have menstruated in the past 12 months
You will not qualify if you...
- Bladder cancer diagnosis within the last three years
- Synchronous bilateral upper tract urothelial carcinoma (prior contralateral UTUC allowed if disease-free for more than three years)
- Planned radical cystectomy
- Small bladder capacity less than 100 mL
- History of allergic reactions to gemcitabine or similar agents
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
Y
Yair Lotan, MD
CONTACT
P
Phillip McDuffie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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