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

NCT06262516 | Recruiting DMC

• 1 other identifier: CASE2824
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 4

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.

Conditions

Urothelial Carcinoma

Keywords

Nephroureterectomy; Kidney and ureter; Upper Tract Urothelial Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

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

  2 years post-op

Secondary Outcomes (6)

• Treatment-free survival

  2 years post-op

• Cancer-specific survival

  2 years post-op

• Overall Survival

  2 years post-op

• Time to recurrence

  2 years post-op

• Use of adjuvant therapies

  2 years post-op

Study Arms (2)

Nephroureterectomy With Lymph Node Dissection

EXPERIMENTAL

Participants will undergo nephroureterectomy for UTUC and will receive LND.

Procedure: Nephroureterectomy; Procedure: Lymph Node Dissection

Nephroureterectomy Without Lymph Node Dissection

ACTIVE COMPARATOR

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

Procedure: Nephroureterectomy

Interventions

Nephroureterectomy PROCEDURE

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

Nephroureterectomy With Lymph Node Dissection; Nephroureterectomy Without Lymph Node Dissection

Lymph Node Dissection PROCEDURE

Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Nephroureterectomy With Lymph Node Dissection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (4)

University of Florida Health Science Center

Gainesville, Florida, 32209, United States

RECRUITING

Southern Illinois University

Springfield, Illinois, 62702, United States

RECRUITING

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

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic Glickman Urological and Kidney Institute

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Nephroureterectomy; Lymph Node Excision

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Nephrectomy; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mohamed Eltemamy, MD

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

  PRINCIPAL INVESTIGATOR

• Adam Calaway, MD, MPH

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Eltemamy, MD

CONTACT

216-444-5888; Eltemam@ccf.org

Rebecca Campbell, MD

CONTACT

216-444-1105; CAMPBER7@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a 1:1 two armed randomized-controlled trial.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 16, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: From when the trial starts (receives IRB approval and recruitment is initiated) until 1 year after the final participant finishes 2 year follow-up.
• Access Criteria: This will be shared with the following people at UH PI, research coordinator, residents/fellows/other attendings who are included on the IRB at UH.

Locations

US (4)