Recruiting
Phase 3

Gemcitabine vs. Water Irrigation

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT04865939

Conditions

Urothelial Cancer of Renal Pelvis

Urothelial Carcinoma Ureter

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

sterile water irrigation

Gemcitabine

Study Details

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 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

Urothelial Cancer of Renal Pelvis

Urothelial Carcinoma Ureter

Study ID

NCT04865939

Start date

Nov 29, 2021

Status verified date

Aug, 2026

Completion date

Nov 1, 2031

Anticipated

Primary completion date

Nov 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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 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 Criteria:

  • 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.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: gemcitabine

intravesical instillation of gemcitabine (1 g in 50 mL saline) with dwell time of 1 - 3 hours

experimental: sterile water irrigation

intravesical continuous bladder irrigation with sterile water for 1 - 3 hours and a total instilled volume of approximately 4 - 16 liters

Interventions

sterile water irrigation

Continuous irrigation of bladder with sterile water during surgery (prior to entry into bladder).

Gemcitabine

Intravesical gemcitabine instilled into bladder during surgery (drained prior to entry into bladder).

Primary outcome measure

  • intravesical recurrence [ Time Frame: 1 year ]
  • intravesical recurrence [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Corey Nixon, MD

(214) 645-8787corey.nixon@utsouthwestern.edu

Phillip McDuffie, MD

214-645-8787phillip.mcduffie@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Yair Lotan, MD

(214) 648-0389yair.lotan@utsouthwestern.edu

Principal Investigator:

Yair Lotan, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-08-17.