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.
Adults > 18 years
Diagnosis of UTUC as determined by upper tract biopsy (either low or high grade)
Planned for nephroureterectomy by their urologic surgeon
Disease that is ≤cT4, N0M0. Participants must have complete TNM staging prior to surgery. cT disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (CT/MRI). cN and cM stage must be determined by preoperative imaging of the chest, abdomen and pelvis.
Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (>cN0)
Presence of distant metastases
Concomitant muscle invasive bladder cancer
The participant is in a reduced general condition or has a life-threatening disease.
Parallel
Nephroureterectomy
Procedure/SurgeryParticipants will undergo standard-of-care nephroureterectomy for UTUC.
Lymph Node Dissection
Procedure/SurgeryParticipants will receive lymph node dissection alongside nephroureterectomy for UTUC.
Recurrence-free survival
Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND.
Treatment-free survival
Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND.
Cancer-specific survival
Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND.
Overall Survival
Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND.
Time to recurrence
Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND.
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