Recruiting

Nephroureterectomy

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06262516

Conditions

Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Nephroureterectomy

Lymph Node Dissection

Study Details

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

Study ID

NCT06262516

Start date

May 17, 2024

Status verified date

Sep, 2025

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nephroureterectomy With Lymph Node Dissection

Participants will undergo nephroureterectomy for UTUC and will receive LND.

active comparator: Nephroureterectomy Without Lymph Node Dissection

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

Interventions

Nephroureterectomy

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

Lymph Node Dissection

Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Primary outcome measure

  • Recurrence-free survival [ Time Frame: 2 years post-op ]

Central Contacts and Locations

Central contacts

Mohamed Eltemamy, MD

216-444-5888Eltemam@ccf.org

Rebecca Campbell, MD

216-444-1105CAMPBER7@ccf.org

Locations

University of Florida Health Science Center

Recruiting

Gainesville, Florida, United States, 32209

Southern Illinois University

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Mohammad Mahmoud, MD

mmahmoud96@siumed.edu

Principal Investigator:

Mohammad Mahmoud, MD

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

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Adam Calaway, MD, MPH

Adam.Calaway@UHhospitals.org

Principal Investigator:

Adam Calaway, MD, MPH

Cleveland Clinic Glickman Urological and Kidney Institute

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Mohamed Eltemamy, MD

216-444-5888Eltemam@ccf.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Sep 5, 2025

Last verified

Sep, 2025

Keywords

  • Nephroureterectomy
  • Kidney and ureter
  • Upper Tract Urothelial Cell Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2025-09-05.