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

Last updated: September 3, 2025
Sponsor: Case Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Urothelial Carcinoma

Treatment

Lymph Node Dissection

Nephroureterectomy

Clinical Study ID

NCT06262516
CASE2824
  • Ages > 19
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 tosurgery. cT disease can be determined by biopsy of the mass (if biopsy was deepenough) or imaging (CT/MRI). cN and cM stage must be determined by preoperativeimaging 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 writteninformed consent document.

Exclusion

Exclusion Criteria:

  • Pathologically enlarged lymph nodes suspicious for metastases which would requirelymph 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 understandingthe consent process.

  • The patient is pregnant

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: Lymph Node Dissection
Phase:
Study Start date:
May 17, 2024
Estimated Completion Date:
January 01, 2029

Study 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

Connect with a study center

  • University of Florida Health Science Center

    Gainesville, Florida 32209
    United States

    Site Not Available

  • University of Florida Health Science Center

    Gainesville 4156404, Florida 4155751 32209
    United States

    Active - Recruiting

  • Southern Illinois University

    Springfield 4250542, Illinois 4896861 62702
    United States

    Active - Recruiting

  • Cleveland Clinic Glickman Urological and Kidney Institute

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Cleveland Clinic Glickman Urological and Kidney Institute

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

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

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

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