This phase III trial compares the effect of bladder irrigation with hypotonic water to chemotherapy wash with gemcitabine for the prevention of bladder cancer in patients with upper tract urothelial cancer. Currently, some urologists use a chemotherapy wash of the bladder at the start of surgery to remove the kidney or ureter to reduce this risk of cancer coming back (recurrence). Irrigating the bladder with hypotonic water may wash out cancer cells and reduce recurrence of cancer in the bladder.
Additional locations may be listed on ClinicalTrials.gov for NCT04865939.
Locations matching your search criteria
United States
Texas
Dallas
UT Southwestern/Simmons Cancer Center-DallasStatus: Active
Contact: Yair Lotan
Phone: 214-645-8787
PRIMARY OBJECTIVE:
I. To determine whether intravesical irrigation with sterile water is noninferior to intravesical instillation of gemcitabine to prevent bladder cancer recurrence after surgical resection of upper tract urothelial carcinoma .
SECONDARY OBJECTIVE:
I. To determine the safety of intravesical irrigation with sterile water as compared with intravesical instillation of gemcitabine.
OUTLINE: Patients will be randomized in 1 of 2 arms.
Arm I: Patients receive sterile water via intravesical infusion bladder during surgery (drained prior to entry into bladder).
Arm II: Patients receive gemcitabine via intravesical infusion bladder during surgery (drained prior to entry into bladder).
After completion of study treatment, patients are followed up for 2 years.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorYair Lotan