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New treatment option for Locally Advanced Urothelial Carcinoma
Official title Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
ClinicalTrials.gov ID: NCT07048457
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- If applicable, must be a surgical candidate for resection of non-irradiated metastatic lesion(s) at the discretion of the treating surgeon.
You likely can't join if
- Participants who meet any of the following criteria will be excluded from study entry.
- 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...
- Have any medical condition that, in the treating investigator's opinion, poses an undue risk to the participant's participation in the study.
See the full eligibility criteria
- 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 and the treatment duration must have not exceeded six months from the...
- 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...
- Participants who meet any of the following criteria will be excluded from study entry.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.