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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT06262516
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 17, 2024
Status verified
Sep 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2029

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nephroureterectomy With Lymph Node Dissection
    Participants will undergo nephroureterectomy for UTUC and will receive LND.
  • Active Comparator: Nephroureterectomy Without Lymph Node Dissection
    Participants will undergo nephroureterectomy for UTUC and will not receive LND.

Primary Outcome Measure

Recurrence-free survival [ Time Frame: 2 years post-op ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Florida Health Science CenterGainesvilleFlorida32209
Tarik Benidir, MD
Tarik Benidir, MD (SUB_INVESTIGATOR)
Southern Illinois UniversitySpringfieldIllinois62702
Mohammad Mahmoud, MD
[email protected]
Mohammad Mahmoud, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Glickman Urological and Kidney InstituteClevelandOhio44195
Mohamed Eltemamy, MD
[email protected]
216-444-5888
University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer CenterClevelandOhio44106
Adam Calaway, MD, MPH
[email protected]
Adam Calaway, MD, MPH (PRINCIPAL_INVESTIGATOR)

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University of Florida Health Science Center· Gainesville, FLSouthern Illinois University· Springfield, ILCleveland Clinic Glickman Urological and Kidney Institute· Cleveland, OHUniversity Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center· Cleveland, OH

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