Surgery after systemic treatment in bladder and urothelial cancer that has spread
Tests surgery to remove the bladder after treatment in adults with urothelial cancer.
Plain-language title generated from the registry record
Registry title: Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
Key facts
- Where
- Madison and New Haven, United StatesSee the 2 sites
- Phase
- Phase 2
Where in United States
- University of Wisconsin - MadisonMadison, United StatesNot yet recruiting
- Yale UniversityNew Haven, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yale University
- Trial code
- NCT07048457
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
A Phase II Study of Consolidative Local Therapy in Patients With Locally Advanced or Oligo-metastatic Urothelial Carcinoma (la/mUC) Following Treatment Response to Systemic Therapy With or Without Metastasis-directed Radiotherapy
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.
Inclusion: Be at least 18 years of age; Have provided informed consent; Have ECOG Performance status of 0 or 1; Be surgical candidate for extirpative surgery of primary site with standard bilateral pelvic lymph node dissection and urinary diversion at the discretion of urological oncologist; If applicable, must be a surgical candidate for resection of non-irradiated metastatic lesion(s) at the discretion of the treating surgeon; Have adequate organ function as defined by:; Hgb >9.0 ng/dL; WBC >3.0 K/mcL; PLT >100 K /mcL; AST <3.0 x ULN U/L; ALT <3.0 x ULN U/L; Total Bilirubin <2.0 x UNL mg/dL; Disease characteristics:; Have histologically confirmed diagnosis of locally advanced or oligo-metastatic urothelial carcinoma defined by presence of five or few distinct metastatic lesions at the time of diagnosis of metastatic disease; If variant histology present, it must be <50% and UC must be predominant; Must have begun the first cycle of enfortumab-vedotin-based first-line therapy at least three months prior to the surgery and have continued therapy. Treatment interruption, modification and discontinuation due to adverse events are allowed. Metastasis-directed radiotherapy (MDRT) is allowed; The most recent restaging scan prior to signing ICD must show stable disease, partial response or complete response per treating investigator-assessed RECIST v1.1. In case of stable disease or partial response, MDRT is highly recommended. Enrollment of such participants should be discussed with the PI.
Exclusion: Received systemic anti-cancer therapy within three weeks prior to the surgery; Received radiotherapy within two weeks prior to the surgery; Have other concurrent medical, surgical or psychiatric conditions that, in the treating investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations; Have any medical condition that, in the treating investigator's opinion, poses an undue risk to the participant's participation in the study; Have history of central nervous system (CNS) metastasis and/or leptomeningeal metastasis; Have a positive serum pregnancy test or women who are breastfeeding; Participants who meet any of the following criteria will be excluded from study entry.