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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Case Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT06262516

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Nephroureterectomy (Procedure)
    Participants will undergo standard-of-care nephroureterectomy for UTUC.
  • Lymph Node Dissection (Procedure)
    Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Eligibility criteria

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 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. Exclusion Criteria: * 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

Conditions

Urothelial Carcinoma

Locations

  • 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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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record