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

Recruiting now · Not applicable

Conditions studied: Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT06262516

Run by

Case Comprehensive Cancer Center

People needed

94

Starts

2024-05-17

Expected to finish

2029-01-01

Last updated by the study team

2025-09-05

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• No concomitant muscle-invasive bladder cancer
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• 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.
• The participant has a psychiatric disorder that precludes them from understanding the consent process.
• The patient is pregnant

Where it is running

• University of Florida Health Science Center — Gainesville, Florida, United States (enrolling)
• Southern Illinois University — Springfield, Illinois, United States (enrolling)
• University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (enrolling)
• Cleveland Clinic Glickman Urological and Kidney Institute — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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