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

NCT ID: NCT06262516Sponsor: Case Comprehensive Cancer CenterLast updated: 2025-09-05

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.

Detailed 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

Arms & interventions

  • ProcedureNephroureterectomy

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

  • ProcedureLymph Node Dissection

    Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Outcome measures

Primary

  • Recurrence-free survival

    Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND.

    Time frame: 2 years post-op

Secondary

  • Treatment-free survival

    Time frame: 2 years post-op

  • Cancer-specific survival

    Time frame: 2 years post-op

  • Overall Survival

    Time frame: 2 years post-op

  • Time to recurrence

    Time frame: 2 years post-op

  • Use of adjuvant therapies

    Time frame: 2 years post-op

  • Perioperative complications

    Time frame: 2 years post-op

Eligibility criteria

Sex: AllAge: 19 Years and olderHealthy volunteers: No
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

Study locations (4)

University of Florida Health Science Center

Gainesville, Florida, 32209

Recruiting
Tarik Benidir, MD · Contact
Tarik Benidir, MD · Sub Investigator

Southern Illinois University

Springfield, Illinois, 62702

Recruiting
Mohammad Mahmoud, MD · Contact
mmahmoud96@siumed.edu
Mohammad Mahmoud, MD · Principal Investigator

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

Cleveland, Ohio, 44106

Recruiting
Adam Calaway, MD, MPH · Contact
Adam.Calaway@UHhospitals.org
Adam Calaway, MD, MPH · Principal Investigator

Cleveland Clinic Glickman Urological and Kidney Institute

Cleveland, Ohio, 44195

Recruiting
Mohamed Eltemamy, MD · Contact
216-444-5888Eltemam@ccf.org