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Nephroureterectomy with and without Lymph Node Dissection for the Treatment of Upper Tract Urothelial Cancer
Trial Status: active
This clinical trial compares the effect of a nephroureterectomy with a lymph node dissection to a nephroureterectomy without a lymph node dissection for the treatment of patients with kidney and/or ureter cancer (upper tract urothelial cancer). Each kidney drains urine into a ureter which is a tube that connects the kidney to the bladder. In addition to draining urine into the bladder, the kidney and ureter also drain lymphatic fluid into nearby lymph nodes which are small lumps of tissue that contain white blood cells. The job of lymph nodes is to help fight infection, however, sometimes cancer can spread to the lymph nodes. Current treatment for upper tract urothelial cancer is surgical removal of the kidney and ureter (nephroureterectomy). Removal of the nearby lymph nodes (lymph node dissection) during surgery may also be recommended, however, because it is a rare cancer, there is little evidence to support the recommendation. Nephroureterectomy with lymph node dissection may be effective compared to without lymph node dissection in treating patients with upper tract urothelial cancer.
Inclusion Criteria
Adults > 18 years
Diagnosis of upper tract urothelial carcinoma (UTUC) as determined by upper tract biopsy (either low or high grade)
Planned for nephroureterectomy by their urologic surgeon
Disease that is ≤ cT4, N0M0. Patients 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/magnetic resonance imaging [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 patient is in a reduced general condition or has a life-threatening disease
The patient has a psychiatric disorder that precludes them from understanding the consent process
Additional locations may be listed on ClinicalTrials.gov for NCT06262516.
I. To determine oncologic outcomes, specifically 2-year recurrence-free survival.
SECONDARY OBJECTIVES:
I. To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival.
II. To determine time to recurrence and recurrence patterns.
III. To determine use of adjuvant therapies.
IV. To determine perioperative complications.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo nephroureterectomy and lymph node dissection on day 1. Additionally, patients may undergo cystoscopy, computed tomography (CT) or magnetic resonance (MR) urography throughout the study.
ARM II: Patients undergo nephroureterectomy on day 1. Additionally, patients may undergo cystoscopy, CT or MR urography throughout the study.
After completion of study intervention, patients are followed up for up to 2 years.
