Consolidative Local Therapy for Urothelial Carcinoma
This study is looking at a treatment called consolidative local therapy (CLT) for people with locally advanced or oligo-metastatic urothelial carcinoma (a type of bladder cancer that has spread to a few other places). The CLT involves a surgery called radical cystectomy (removal of the bladder) along with removal of lymph nodes and any tumors that can be surgically removed or have been treated with radiation. This treatment is for patients whose cancer has responded well to a prior medication called enfortumab vedotin. The main goal is to see how many patients are still free from cancer progression 12 months after surgery. The study is currently recruiting 32 participants.
- Study design
- This is a single-arm, open-label, Phase 2 study, meaning all participants receive the same treatment and everyone knows what treatment is being given. It plans to enroll 32 participants.
- What's involved
- You would undergo definitive surgical management, including radical cystectomy with bilateral pelvic lymph node dissection and urinary diversion, and metastasectomy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be measured 12 months after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Fed Ghali, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- 12-Month Progression-Free Survival in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma12 month post-surgery
The primary outcome measure for this study is to evaluate the 12-month progression-free survival of consolidative therapy in participants with locally advanced or oligo-metastatic urothelial carcinoma (UC). PFS will be assessed by measuring the time from the initiation of consolidative therapy to the occurrence of disease progression or death from any cause, whichever comes first. The primary endpoint for this outcome measure is the one-year progression-free survival rate, which represents the proportion of patients remaining free from disease progression or death at 12 months following the treatment. Data collected will provide insight into the efficacy of consolidative therapies in prolonging disease stability and improving survival outcomes for this patient population.