Comparing gemcitabine and water irrigation for bladder cancer recurrence prevention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of intravesical gemcitabine versus sterile water irrigation in preventing bladder cancer recurrence after surgery for upper tract urothelial carcinoma. The study involves patients who have undergone radical nephroureterectomy and will assess recurrence rates of urothelial carcinoma in the bladder following these two different interventions. By evaluating the outcomes, the trial seeks to determine if sterile water irrigation can serve as a viable alternative to chemotherapy in this context. The study is designed to provide insights into the management of bladder cancer recurrence, which is a significant concern for patients after surgery.

Why it matters

Who can join: the full rules

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 of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  * Has not undergone a hysterectomy or bilateral oophorectomy; or
  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Concurrent or prior diagnosis of bladder cancer with a disease-free interval of less than three years.
* Synchronous bilateral upper tract urothelial carcinoma (prior history of contralateral UTUC is permissible with a disease-free interval of more than three years).
* Plan for radical cystectomy.
* Small bladder capacity (\< 100 mL).
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or other agents used in study.

Where it's running

• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Yair Lotan, MD — University of Texas Southwestern Medical Center
• Study coordinator: Corey Nixon, MD
• Email: corey.nixon@utsouthwestern.edu
• Phone: (214) 645-8787

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry of patients with upper tract urothelial cancer treated with Jelmyto

  This study is looking at how well Jelmyto works for people with upper tract urothelial cancer by tracking their experiences and outcomes over time.

  Recruiting at 22 sites UroGen Pharma Ltd. · Santa Monica, California and 21 other locations · NCT05874921

• Combining kidney-sparing surgery with postoperative radiotherapy for advanced ureteral cancer

  This study is testing if a new approach that combines kidney-sparing surgery with radiation after surgery can safely treat advanced ureteral cancer while keeping kidney function intact.

  Recruiting at 2 sites Peking University First Hospital · Beijing and 1 other locations · NCT06120387

• Tirzepatide for methamphetamine use disorder (phase 2)

  This phase 2 trial tests whether weekly tirzepatide injections can help adults with moderate to severe methamphetamine use disorder reduce use and improve outcomes compared with placebo.

  Recruiting Phase 2 University of Texas Southwestern Medical Center · Los Angeles, California and 3 other locations · NCT07825857

• Do beverage cues drive craving in adults with AUD

  In adults with alcohol use disorder, this study tests whether different non-alcoholic beverage cues can trigger cravings differently when people see and smell them without drinking.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT07788716

• How foot braces might help people with ataxia walk better

  This study tests whether wearing foot orthoses at home can improve gait and balance for adults with cerebellar ataxia.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT07720700

• Personalized Ultrafractionated Stereotactic Radiotherapy with Perioperative FLOT for GEJ and Esophageal Cancer

  This trial tests adding a personalized, ultra-fractionated radiotherapy boost (PULSAR) to standard perioperative FLOT chemotherapy for patients with esophageal or gastroesophageal junction cancer to see if it can be used safely.

  Recruiting Phase 1 University of Texas Southwestern Medical Center · Dallas, Texas · NCT07700420

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.