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NCT Number: NCT06262516

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

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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Health Science Center, Gainesville, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recurrence-free survival

    Time frame: 2 years post-op

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

Secondary outcomes

  1. Treatment-free survival

    Time frame: 2 years post-op

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

  2. Cancer-specific survival

    Time frame: 2 years post-op

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

  3. Overall Survival

    Time frame: 2 years post-op

    Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND.

  4. Time to recurrence

    Time frame: 2 years post-op

    Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND.

  5. Use of adjuvant therapies

    Time frame: 2 years post-op

    T-test or the Wilcoxon rank-sum test will be applied to determine the rate of adjuvant therapies used between participants who received LND vs participants who did not receive LND.

  6. Perioperative complications

    Time frame: 2 years post-op

    T-test or the Wilcoxon rank-sum test will be applied to determine the rate of perioperative complications between participants who received LND vs participants who did not receive LND.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Eltemamy, MD

CONTACT

[email protected]

216-444-5888

Rebecca Campbell, MD

CONTACT

[email protected]

216-444-1105

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Feb 16, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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