Urothelial CarcinomaNCT06262516
Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
A study testing Nephroureterectomy and Lymph Node Dissection in people with Urothelial Carcinoma, run by Case Comprehensive Cancer Center at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Nephroureterectomy and Lymph Node Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 May 2024to 1 Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Adam Calaway, MD, MPH, Adam.Calaway@UHhospitals.org
Adam Calaway, MD, MPH
- Recruiting
Cleveland Clinic Glickman Urological and Kidney Institute
Cleveland, Ohio, 44195
Mohamed Eltemamy, MD, 216-444-5888, Eltemam@ccf.org
- Recruiting
University of Florida Health Science Center
Gainesville, Florida, 32209
Tarik Benidir, MD
Tarik Benidir, MD
- Recruiting
Southern Illinois University
Springfield, Illinois, 62702
Mohammad Mahmoud, MD, mmahmoud96@siumed.edu
Mohammad Mahmoud, MD
About this study
Official title: Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
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.
Read the 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
- Conditions
- Urothelial Carcinoma
- Being tested
- Nephroureterectomy, Lymph Node Dissection
- Keywords
- Nephroureterectomy, Kidney and ureter, Upper Tract Urothelial Cell Carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NephroureterectomyProcedure or surgery
Participants will undergo standard-of-care nephroureterectomy for UTUC.
Lymph Node DissectionProcedure or surgery
Participants will receive lymph node dissection alongside nephroureterectomy for UTUC.
| Study group | Role | What they receive |
|---|---|---|
| Nephroureterectomy With Lymph Node Dissection | Experimental | Participants will undergo nephroureterectomy for UTUC and will receive LND. Receives: Procedure: Nephroureterectomy; Procedure: Lymph Node Dissection |
| Nephroureterectomy Without Lymph Node Dissection | Active comparator | Participants will undergo nephroureterectomy for UTUC and will not receive LND. Receives: Procedure: Nephroureterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND.
Measured: 2 years post-op
Secondary outcomes (6)
Treatment-free survival
Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND.
Measured: 2 years post-op
Cancer-specific survival
Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND.
Measured: 2 years post-op
Overall Survival
Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND.
Measured: 2 years post-op
Time to recurrence
Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND.
Measured: 2 years post-op
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.
Measured: 2 years post-op
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.
Measured: 2 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start17 May 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a 1:1 two armed randomized-controlled trial.
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Eltemamy, MD, Principal investigator, Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer CenterAdam Calaway, MD, MPH, Principal investigator, University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262516
- Sponsor's protocol ID
- CASE2824
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This will be shared via a redcap database. All of the variables listed in the PRMC protocol and IRB application will be shared.