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Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

NCT04865939 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

PROCEDURE

sterile water irrigation

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

DRUG

Gemcitabine

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2029-11-01
Completion
2031-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865939 on ClinicalTrials.gov