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

Case Comprehensive Cancer Center (Case CCC)

Status: Enrolling

Conditions: Urothelial Carcinoma

Treatments: Procedure: Nephroureterectomy; Procedure: Lymph Node Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06262516

CASE2824

Details and patient eligibility

About

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.

Full 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

Enrollment: 94 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Nephroureterectomy With Lymph Node Dissection

Experimental group

Description:

Participants will undergo nephroureterectomy for UTUC and will receive LND.

Treatment:

Procedure: Lymph Node Dissection

Procedure: Nephroureterectomy

Nephroureterectomy Without Lymph Node Dissection

Active Comparator group

Description:

Participants will undergo nephroureterectomy for UTUC and will not receive LND.

Treatment:

Procedure: Nephroureterectomy