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

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

Who can join

Ages 19 and older · All sexes

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

About the study

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.

What is being tested

• Nephroureterectomy (procedure)
• Lymph Node Dissection (procedure)

Sponsor: Case Comprehensive Cancer Center · Participants: 94 · Started: May 17, 2024

Contact the study team

• Mohamed Eltemamy, MD · Phone: 216-444-5888
• Rebecca Campbell, MD · Phone: 216-444-1105

Official record on ClinicalTrials.gov — NCT06262516

Locations in the U.S.

Conditions

• Urothelial (Transitional Cell) Carcinoma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.