Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• Have a positive serum pregnancy test or women who are breastfeeding.

Egyéb

• Participants who meet any of the following criteria will be excluded from study entry.

• 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.