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

Launched by CASE COMPREHENSIVE CANCER CENTER · Feb 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a surgical procedure called nephroureterectomy, which involves removing the kidney and part of the ureter, in patients with a type of cancer called upper tract urothelial cell carcinoma (UTUC). The trial aims to find out if removing nearby lymph nodes during this surgery helps improve outcomes for patients, such as reducing the chances of cancer returning after treatment. Researchers will compare two groups: one group will have the lymph nodes removed, while the other group will not. They will look at various factors, including how long people stay cancer-free and any complications that may arise from the surgery.

To participate in this trial, adults over 18 years old who have been diagnosed with UTUC and are scheduled for nephroureterectomy may be eligible. Candidates must have certain characteristics, such as having cancer that has not spread to nearby lymph nodes or distant organs. Participants can expect to undergo the surgery as planned, and they will be closely monitored for their recovery and any signs of cancer recurrence. It's important for potential participants to understand the study and agree to take part by signing a consent form.

Gender

ALL

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