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Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma

Urothelial Carcinoma Clinical Trial

Official title:
Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06262516
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Mohamed Eltemamy, MD
Phone 216-444-5888
Email Eltemam@ccf.org
Status Recruiting
Phase N/A
Start date May 17, 2024
Completion date January 1, 2029
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