Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
Case Comprehensive Cancer Center
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.
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 surviv…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
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 writte…
Interventions
- ProcedureNephroureterectomy
Participants will undergo standard-of-care nephroureterectomy for UTUC.
- ProcedureLymph Node Dissection
Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.
Locations (4)
- University of Florida Health Science CenterGainesville, Florida
- Southern Illinois UniversitySpringfield, Illinois
- University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer CenterCleveland, Ohio
- Cleveland Clinic Glickman Urological and Kidney InstituteCleveland, Ohio