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Could sterile water match chemotherapy in preventing bladder cancer return?

NCT ID NCT04865939

Prevention Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether rinsing the bladder with sterile water during surgery works as well as a chemotherapy drug (gemcitabine) placed directly into the bladder to prevent cancer from coming back. People with upper tract urothelial carcinoma who are having surgery to remove the affected kidney or ureter may join. The goal is to see which approach better reduces the chance of bladder cancer recurrence after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intravesical gemcitabine (chemotherapy placed directly into the bladder) compared with continuous bladder irrigation with sterile water during surgery
What this could lead to
If sterile water works as well as gemcitabine, it could offer a simpler, cheaper, and more accessible way to prevent bladder cancer from returning after surgery for upper tract urothelial carcinoma.
What could go wrong
This is a phase 3 trial, but results may not confirm that sterile water is equally effective. There is also a risk of side effects from gemcitabine, such as bladder irritation or other complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

renal pelvis urothelial carcinoma renal pelvis/ureter urothelial carcinoma ureter transitional cell carcinoma urinary bladder carcinoma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urothelial cancer of renal pelvis Urothelial carcinoma ureter

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

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