Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Received systemic anti-cancer therapy within three weeks prior to the surgery.
Received radiotherapy within two weeks prior to the surgery.
Have a positive serum pregnancy test or women who are breastfeeding.
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.
Trial design
Treatments tested in this trial
- Radical cystectomy
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Yale University
Lead sponsor
Medical College of Virginia Foundation
Collaborator
Source ClinicalTrials.gov