NCT04865939RecruitingPhase 3

Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

A Randomized Trial Comparing Intravesical Gemcitabine to Continuous Bladder Irrigation With Sterile Water to Prevent Bladder Cancer Implantation in Patients Undergoing Excision of Upper Tract Urothelial Carcinoma

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 132 (estimated)
First submitted: 26 Apr 2021
Start date: Nov 2021
Primary completion date: Nov 2029
Lead sponsor: University of Texas Southwestern Medical Center
Diseases: Bladder cancer
NCT number: NCT04865939

What you commit to

Study type: Interventional · Phase 3
Planned participants: 132
From Nov 2021 to the primary completion date, Nov 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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).

Other illness

History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or other agents used in study.

Other

Plan for radical cystectomy.
Small bladder capacity (\< 100 mL).

Who the study is looking for

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.

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status	Dallas	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.