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

NCT ID: NCT06262516

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2029-01-01

Brief 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

Conditions

Urothelial Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nephroureterectomy With Lymph Node Dissection

Participants will undergo nephroureterectomy for UTUC and will receive LND.

Group Type: EXPERIMENTAL

Nephroureterectomy

Intervention Type: PROCEDURE

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

Lymph Node Dissection

Intervention Type: PROCEDURE

Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Nephroureterectomy Without Lymph Node Dissection

Participants will undergo nephroureterectomy for UTUC and will not receive LND.

Group Type: ACTIVE_COMPARATOR

Nephroureterectomy

Intervention Type: PROCEDURE

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

Interventions

Nephroureterectomy

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

Intervention Type: PROCEDURE

Lymph Node Dissection

Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Eltemamy, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center

Adam Calaway, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University of Florida Health Science Center

Gainesville, Florida, United States

Site Status: RECRUITING

Southern Illinois University

Springfield, Illinois, United States

Site Status: RECRUITING

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

Cleveland, Ohio, United States

Site Status: RECRUITING

Cleveland Clinic Glickman Urological and Kidney Institute

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mohamed Eltemamy, MD

Role: CONTACT

Eltemam@ccf.org

216-444-5888

Rebecca Campbell, MD

Role: CONTACT

CAMPBER7@ccf.org

216-444-1105

Facility Contacts

Tarik Benidir, MD

Role: primary

Mohammad Mahmoud, MD

Role: primary

mmahmoud96@siumed.edu

Adam Calaway, MD, MPH

Role: primary

Adam.Calaway@UHhospitals.org

Mohamed Eltemamy, MD

Role: primary

Eltemam@ccf.org

216-444-5888

Other Identifiers

CASE2824

Identifier Type: -

Identifier Source: org_study_id