Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Apr 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to help prevent bladder cancer from coming back after surgery for upper tract urothelial carcinoma, which is cancer that affects the kidneys and ureters. The trial is comparing the use of a chemotherapy drug called gemcitabine, which is usually put directly into the bladder during surgery, to using just sterile water to rinse the bladder. Researchers want to see if these two methods are equally effective in keeping cancer from returning.

To be eligible for this study, participants should be between 18 and 90 years old and have a confirmed diagnosis of upper tract urothelial carcinoma, with plans for surgery aimed at curing the cancer. They should also expect to live for at least another year and agree to use birth control if they can become pregnant or father children during the study. Participants will receive treatment and will be monitored to see how well each method works in preventing cancer recurrence. It's important to note that this study is currently recruiting participants, so those who meet the criteria and are interested can consider joining.

Gender

ALL

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 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.