The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are: * To determine oncologic outcomes, specifically 2-year recurrence-free survival * To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival * To determine time to recurrence and recurrence patterns * To determine use of adjuvant therapies * To determine perioperative complications Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.
Upper Tract Urothelial Carcinoma (UTUC) is a rare disease with complex management. Some participants with clinically negative nodes may still receive a lymph node dissection (LND) with nephroureterectomy, and currently, no randomized controlled trial exists to evaluate the oncologic efficacy of this practice. According to current American Urologic Association guidelines, Nephroureterectomy is the standard of care intervention for high-risk UTUC and low-risk UTUC is endoscopically unresectable. The aim of the present study is to determine the efficacy, specifically 2-year recurrence-free survival, of lymph node dissection at time of nephroureterectomy for participants with UTUC, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Participants will undergo standard-of-care nephroureterectomy for UTUC.
Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.
University of Florida Health Science Center
Gainesville, Florida, United States
RECRUITINGSouthern Illinois University
Springfield, Illinois, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
RECRUITINGCleveland Clinic Glickman Urological and Kidney Institute
Cleveland, Ohio, United States
RECRUITINGRecurrence-free survival
Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Treatment-free survival
Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Cancer-specific survival
Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Overall Survival
Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Time to recurrence
Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Use of adjuvant therapies
T-test or the Wilcoxon rank-sum test will be applied to determine the rate of adjuvant therapies used between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
Perioperative complications
T-test or the Wilcoxon rank-sum test will be applied to determine the rate of perioperative complications between participants who received LND vs participants who did not receive LND.
Time frame: 2 years post-op
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