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Trial Title:
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
NCT ID:
NCT06262516
Condition:
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Conditions: Keywords:
Nephroureterectomy
Kidney and ureter
Upper Tract Urothelial Cell Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study is designed as a 1:1 two armed randomized-controlled trial.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Nephroureterectomy
Description:
Participants will undergo standard-of-care nephroureterectomy for UTUC.
Arm group label:
Nephroureterectomy With Lymph Node Dissection
Arm group label:
Nephroureterectomy Without Lymph Node Dissection
Intervention type:
Procedure
Intervention name:
Lymph Node Dissection
Description:
Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.
Arm group label:
Nephroureterectomy With Lymph Node Dissection
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.
Detailed 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
Criteria for eligibility:
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.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adam Calaway, MD, MPH
Email:
Adam.Calaway@UHhospitals.org
Investigator:
Last name:
Adam Calaway, MD, MPH
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Glickman Urological and Kidney Institute
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mohamed Eltemamy, MD
Phone:
216-444-5888
Email:
Eltemam@ccf.org
Start date:
May 17, 2024
Completion date:
January 1, 2029
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06262516
