Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

Recruiting Phase 3 Interventional Study
Urothelial Cancer of Renal Pelvis Urothelial Carcinoma Ureter
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
University of Texas Southwestern Medical Center · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
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 …
Contacts

Yair Lotan, MD

(214) 648-0389

yair.lotan@utsouthwestern.edu

CONTACT

Phillip McDuffie

214-645-8787

CONTACT