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

Urothelial Carcinoma Clinical Trial

Official title:

Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262516
• Other study ID #: CASE2824
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2024
• Est. completion date: January 1, 2029

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Mohamed Eltemamy, MD
• Phone: 216-444-5888
• Email: Eltemam[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Urothelial Carcinoma

Intervention

Procedure:
• Nephroureterectomy
Participants will undergo standard-of-care nephroureterectomy for UTUC.
• Lymph Node Dissection
Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.

Locations

Country	Name	City	State
United States	Cleveland Clinic Glickman Urological and Kidney Institute	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival	Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND.	2 years post-op
Secondary	Treatment-free survival	Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND.	2 years post-op
Secondary	Cancer-specific survival	Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND.	2 years post-op
Secondary	Overall Survival	Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND.	2 years post-op
Secondary	Time to recurrence	Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND.	2 years post-op
Secondary	Use of adjuvant therapies	T-test or the Wilcoxon rank-sum test will be applied to determine the rate of adjuvant therapies used between participants who received LND vs participants who did not receive LND.	2 years post-op
Secondary	Perioperative complications	T-test or the Wilcoxon rank-sum test will be applied to determine the rate of perioperative complications between participants who received LND vs participants who did not receive LND.	2 years post-op