Comparing gemcitabine and water irrigation for bladder cancer recurrence prevention
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
This study is testing whether using gemcitabine or sterile water after surgery can help prevent bladder cancer from coming back in patients who had their kidney and ureter removed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04865939 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 90 with biopsy-proven upper tract urothelial carcinoma scheduled for excisional surgery.
Not a fit: Patients with a life expectancy of less than one year or those who are not planning to undergo excisional surgery for their cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and potentially safer method for preventing bladder cancer recurrence in patients undergoing surgery for upper tract urothelial carcinoma.
How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly in the use of intravesical chemotherapy for bladder cancer recurrence prevention.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Yair Lotan, MD
- Email: yair.lotan@utsouthwestern.edu
- Phone: (214) 648-0389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.