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

NCT06262516 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-09-05

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Nephroureterectomy

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

PROCEDURE

Lymph Node Dissection

Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Mohamed Eltemamy, MD · Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center

  • Adam Calaway, MD, MPH · University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2027-01-01
Completion
2029-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06262516 on ClinicalTrials.gov