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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Urothelial Carcinoma
Intervention / Treatment

-

Contacts and Locations

Cleveland

University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States, 44106

Cleveland

Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Comprehensive Cancer Center,

Mohamed Eltemamy, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center

Adam Calaway, MD, MPH, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center

Study Record Dates

2029-01-01