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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
University of Florida Health Science Center
RECRUITING
Gainesville
Illinois
Southern Illinois University
RECRUITING
Springfield
Ohio
Cleveland Clinic Glickman Urological and Kidney Institute
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Mohamed Eltemamy, MD
Eltemam@ccf.org
216-444-5888
Backup
Rebecca Campbell, MD
CAMPBER7@ccf.org
216-444-1105
Time Frame
Start Date: 2024-05-17
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 94
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov

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