RecruitingPhase 3NCT04865939

Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

A Randomized Trial Comparing Intravesical Gemcitabine to Continuous Bladder Irrigation With Sterile Water to Prevent Bladder Cancer Implantation in Patients Undergoing Excision of Upper Tract Urothelial Carcinoma


Sponsor

University of Texas Southwestern Medical Center

Enrollment

132 participants

Start Date

Nov 29, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches used during surgery for upper urinary tract cancer (cancer in the lining of the kidney or ureter): flushing the urinary tract with gemcitabine (a chemotherapy drug) versus flushing with sterile water, to see which better prevents cancer from coming back. **You may be eligible if...** - You have been diagnosed with upper tract urothelial carcinoma (cancer in the kidney's collecting system or the ureter) confirmed by biopsy - You are planning to have surgery to remove the affected area with curative intent - You are between 18 and 90 years old **You may NOT be eligible if...** - You are pregnant or unwilling to use contraception - Your cancer cannot be surgically removed with curative intent - Your life expectancy is less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREsterile water irrigation

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

DRUGGemcitabine

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


Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT04865939


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