Gemcitabine vs Water Irrigation for Urothelial Cancer

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.
Ready to participate?

Review the details below, then apply to join this clinical trial.

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
Who this trial is looking for

This trial is looking for patients who have a specific type of kidney cancer and will undergo surgery. Participants will compare two methods to prevent the cancer from coming back in the bladder after the surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with upper tract urothelial carcinoma.
  • I am between 18 and 90 years old.
  • I expect to live for more than a year.
  • I will use birth control if I can become pregnant.
  • I can understand and sign a consent form.

You may not be able to join if

  • I have had bladder cancer in the last three years.
  • I have both sides of my upper urinary tract affected.
  • I am planning to have my bladder removed.
  • I have a small bladder capacity (less than 100 mL).
  • I am allergic to gemcitabine or similar medications.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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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

Corey Nixon, MD

(214) 645-8787

corey.nixon@utsouthwestern.edu

CONTACT

Phillip McDuffie, MD

214-645-8787

phillip.mcduffie@utsouthwestern.edu

CONTACT