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

Official title

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

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.

Detailed 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 survival, of lymph node dissection at time of nephroureterectomy for participants with UTUC, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates

Interventions

• Procedure Nephroureterectomy
  Participants will undergo standard-of-care nephroureterectomy for UTUC.
• Procedure Lymph Node Dissection
  Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Primary outcome measures

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

Secondary outcome measures (6)

• Treatment-free survival [Time frame: 2 years post-op]
• Cancer-specific survival [Time frame: 2 years post-op]
• Overall Survival [Time frame: 2 years post-op]
• Time to recurrence [Time frame: 2 years post-op]
• Use of adjuvant therapies [Time frame: 2 years post-op]
• Perioperative complications [Time frame: 2 years post-op]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• University of Florida Health Science Center — Gainesville
• Southern Illinois University — Springfield
• University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cance — Cleveland
• Cleveland Clinic Glickman Urological and Kidney Institute — Cleveland

Identifiers

NCT: NCT06262516 · CASE2824

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗