Actively Recruiting
Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
Led by Yale University · Updated on 2025-12-04
32
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
M
Medical College of Virginia Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study investigates the therapeutic benefit of consolidative local therapy with extirpative surgery for participants with locally advanced or oligo-metastatic urothelial carcinoma that have disease control with enfortumab vedotin-based systemic therapy and surgically resectable or previously radiated metastatic sites.
CONDITIONS
Official Title
Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years of age.
- Have provided informed consent.
- Have ECOG Performance status of 0 or 1.
- Be a surgical candidate for extirpative surgery of the primary site with standard bilateral pelvic lymph node dissection and urinary diversion.
- If applicable, be a surgical candidate for resection of non-irradiated metastatic lesions.
- Have adequate organ function: hemoglobin >9.0 ng/dL, white blood cells >3.0 K/mcL, platelets >100 K/mcL, AST and ALT <3.0 times upper limit of normal, total bilirubin <2.0 mg/dL.
- Have histologically confirmed locally advanced or oligo-metastatic urothelial carcinoma with five or fewer metastatic lesions.
- If variant histology present, it must be less than 50% with urothelial carcinoma predominant.
- Have started enfortumab-vedotin-based first-line therapy at least three months before surgery and treatment duration not exceeding six months.
- Have stable disease, partial response, or complete response on the most recent restaging scan per RECIST v1.1.
- Metastasis-directed radiotherapy is allowed and recommended in cases of stable disease or partial response.
You will not qualify if you...
- Received systemic anti-cancer therapy within three weeks prior to surgery.
- Received radiotherapy within two weeks prior to surgery.
- Have a positive serum pregnancy test or are breastfeeding.
- Have other medical, surgical, or psychiatric conditions that may interfere with study procedures or follow-up.
- Have any medical condition posing undue risk for participation.
- Have a history of central nervous system or leptomeningeal metastasis.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
L
Laura Kane
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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