Surgery for Upper Tract Urothelial Carcinoma with or without Lymph Node Removal
Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
This study is testing whether removing lymph nodes during surgery helps people with upper tract urothelial carcinoma live longer and have fewer cancer recurrences compared to those who don’t have the lymph nodes removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 4 sites (Gainesville, Florida and 3 other locations) |
| Trial ID | NCT06262516 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 diagnosed with upper tract urothelial carcinoma who are scheduled for nephroureterectomy.
Not a fit: Patients with pathologically enlarged lymph nodes or distant metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and survival rates for patients with upper tract urothelial cell carcinoma.
How similar studies have performed: This approach is novel as no prior randomized controlled trials have evaluated the oncologic efficacy of lymph node dissection in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.