RecruitingNot ApplicableNCT06262516

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

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


Sponsor

Case Comprehensive Cancer Center

Enrollment

94 participants

Start Date

May 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for people with upper urinary tract cancer (cancer in the kidney's collecting system or ureter): surgery with removal of nearby lymph nodes versus surgery without. Researchers want to understand whether removing lymph nodes improves outcomes. **You may be eligible if...** - You are an adult over 18 - You have been diagnosed with upper urinary tract urothelial cancer confirmed by biopsy - You are scheduled to have the affected kidney and ureter surgically removed (nephroureterectomy) - Your cancer has not spread to lymph nodes or distant organs (confirmed by imaging) - You do not have invasive bladder cancer at the same time **You may NOT be eligible if...** - Your imaging shows enlarged lymph nodes suspicious for spread - You have cancer that has spread to distant organs - You have simultaneous muscle-invasive bladder cancer - You are in poor general health or have a life-threatening condition - You have a psychiatric disorder preventing informed consent - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENephroureterectomy

Participants will undergo standard-of-care nephroureterectomy for UTUC.

PROCEDURELymph Node Dissection

Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.


Locations(4)

University of Florida Health Science Center

Gainesville, Florida, United States

Southern Illinois University

Springfield, Illinois, United States

University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Glickman Urological and Kidney Institute

Cleveland, Ohio, United States

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NCT06262516


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