Surgery for Upper Tract Urothelial Carcinoma with or without Lymph Node Removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of lymph node dissection during nephroureterectomy for patients with upper tract urothelial cell carcinoma (UTUC). It is the first randomized-controlled trial to assess oncologic outcomes such as 2-year recurrence-free survival, cancer-specific survival, and overall survival. Participants will be assigned to either receive lymph node dissection or not during their surgery, and various outcomes including recurrence patterns and complications will be monitored. The study seeks to provide evidence-based guidance on the necessity of lymph node dissection in the surgical management of UTUC.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Florida Health Science Center
  Gainesville, Florida, United States Recruiting
• Southern Illinois University
  Springfield, Illinois, United States Recruiting
• University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
  Cleveland, Ohio, United States Recruiting
• Cleveland Clinic Glickman Urological and Kidney Institute
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Mohamed Eltemamy, MD — Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center
• Study coordinator: Mohamed Eltemamy, MD
• Email: Eltemam@ccf.org
• Phone: 216-444-5888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.