Status:
RECRUITING
Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Urothelial Cancer of Renal Pelvis
Urothelial Carcinoma Ureter
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
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 intraves...
Detailed Description
Upper tract urothelial carcinoma is a relatively rare disease, accounting for 5-10% of urothelial malignancies. Following radical nephroureterectomy (RNU), recurrence of urothelial carcinoma in the bl...
Eligibility Criteria
Inclusion
- 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 to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- Concurrent or prior diagnosis of bladder cancer with a disease-free interval of less than three years.
- Synchronous bilateral upper tract urothelial carcinoma (prior history of contralateral UTUC is permissible with a disease-free interval of more than three years).
- Plan for radical cystectomy.
- Small bladder capacity (\< 100 mL).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or other agents used in study.
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04865939
Start Date
November 29 2021
End Date
November 1 2031
Last Update
July 17 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390