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Gemcitabine or Water Irrigation for Upper Tract Urothelial Carcinoma

This study is looking at ways to prevent bladder cancer from coming back after surgery for upper tract urothelial carcinoma (cancer in the kidney or the tube connecting the kidney to the bladder). Researchers are comparing two approaches during surgery: using sterile water to rinse the bladder, or using a chemotherapy drug called gemcitabine to rinse the bladder. The goal is to see which method is better at preventing new bladder tumors from forming within one or two years after surgery. You may be able to join if you are between 18 and 90 years old, have this type of cancer, and are planning to have surgery to remove it. The study aims to enroll 132 participants, but its current status is unclear.

Study design
This is an interventional study comparing two different treatments during surgery. It plans to enroll 132 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track whether bladder cancer returns for up to two years after your surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04865939

Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

Recruiting
PHASE3Ages 18–90InterventionalTreatment
University of Texas Southwestern Medical Center
~132 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:sterile water irrigationGemcitabine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
intravesical recurrence
Measured over 1 year
+1 more outcome measured

Conditions

Urothelial Cancer of Renal Pelvis
Urothelial Carcinoma Ureter

Explore related trials

Urothelial Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Yair Lotan, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Corey Nixon, MD
[email protected]
(214) 645-8787
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • intravesical recurrence1 year

    rate of biopsy proven intravesical recurrence of urothelial carcinoma

  • intravesical recurrence2 years

    rate of biopsy proven intravesical recurrence of urothelial carcinoma