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NCT04865939 · ClinicalTrials.gov registry record · Phase 3

Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

A Phase 3 study of Urothelial Cancer of Renal Pelvis and Urothelial Carcinoma Ureter, sponsored by University of Texas Southwestern Medical Center.

Recruiting
Registry status
Phase 3
Development phase
132
Enrollment target
1
Study location

NCT04865939 is a Phase 3 study of Urothelial Cancer of Renal Pelvis and Urothelial Carcinoma Ureter that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 132 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT04865939, a Phase 3 study of Urothelial Cancer of Renal Pelvis and Urothelial Carcinoma Ureter, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.

RECRUITING
Registry status
Phase 3
Development phase
132 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG Gemcitabine
  • PROCEDURE sterile water irrigation

Study Locations (1)

Texas

  • University of Texas Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2021-11-29
Est. Completion 2031-11-01
Phase Phase 3

What the Registry Record Tells You About NCT04865939

The ClinicalTrials.gov registry entry for NCT04865939 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Urothelial Cancer of Renal Pelvis appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.

NCT04865939 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04865939 about?

NCT04865939 is a clinical study titled "Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma". 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 in...

What is the current status of trial NCT04865939?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2021-11-29. Estimated completion is 2031-11-01.

What conditions does trial NCT04865939 study?

This clinical trial studies the following conditions: Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma Ureter.

What interventions are being tested in trial NCT04865939?

The interventions under investigation include: Gemcitabine (DRUG), sterile water irrigation (PROCEDURE).

Who is sponsoring clinical trial NCT04865939?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04865939 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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