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

STU-2021-0402

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 the use of gemcitabine, especially at lower volume centers. Some evidence suggests that intravesical irrigation with sterile water has equivalent efficacy to intravesical chemotherapy in prevention of recurrent bladder cancer following transurethral resection of bladder tumors (TURBT). This study is intended to compare recurrence rates using intravesical gemcitabine (as a pseudo-standard of care) and continuous bladder irrigation with sterile water.

2021-11-29

2027-11-01

2029-11-01

Recruiting

Early phase I

132

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. Female participants who become pregnant or who suspect that they are pregnant should notify the treating investigator immediately. * 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. * 3.2.4 Suspicion for small bladder capacity (\< 100 mL) based on treating urologist's clinical judgment. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or other agents used in study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, single-blinded controlled noninferiority trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Participants will not be informed of group allocation. Blinding treating clinicians is impractical due to the techniques used.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 132, 'type': 'ESTIMATED'}}

2023-12-07