Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04865939
Phase
PHASE3
Status
Recruiting
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Conditions

  • Urothelial Cancer of Renal Pelvis
  • Urothelial Carcinoma Ureter

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • sterile water irrigation — PROCEDURE
    Continuous irrigation of bladder with sterile water during surgery (prior to entry into bladder).
  • Gemcitabine — DRUG
    Intravesical gemcitabine instilled into bladder during surgery (drained prior to entry into bladder).

Study Details

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.

Key Dates

Start date
Nov 29, 2021
Status verified
Jul 2025
Primary completion
Nov 1, 2029
Completion
Nov 1, 2031

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: gemcitabine
    intravesical instillation of gemcitabine (1 g in 50 mL saline) with dwell time of 1 - 3 hours
  • Experimental: sterile water irrigation
    intravesical continuous bladder irrigation with sterile water for 1 - 3 hours and a total instilled volume of approximately 4 - 16 liters

Primary Outcome Measure

intravesical recurrence [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Yair Lotan, MD
[email protected]
(214) 648-0389
Yair Lotan, MD (PRINCIPAL_INVESTIGATOR)
Vitaly Margulis, MD (SUB_INVESTIGATOR)
Aditya Bagrodia, MD (SUB_INVESTIGATOR)
Jeffrey M Howard, MD, PhD (SUB_INVESTIGATOR)
Xiaosong Meng, MD, PhD (SUB_INVESTIGATOR)
Solomon L Woldu, MD (SUB_INVESTIGATOR)

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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