NCT07048457

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a single-arm, open-label, phase 2 clinical trial designed to evaluate the impact of consolidative local therapy in participants with locally advanced/oligo-metastatic urothelial carcinoma (UC) who have demonstrated stable or responsive disease to first-line systemic therapy.

Conditions

• Locally Advanced Urothelial Carcinoma
• Oligo-metastaic Urothelial Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Radical cystectomy	The intervention in this clinical trial consists of definitive surgical management through radical cystectomy with bilateral pelvic lymph node dissection (PLND), urinary diversion, and metastasectomy of surgically resectable or previously radiated metastatic disease. Surgical approach may be either open or robotic, based on surgeon discretion and patient-specific factors. The PLND will be performed in a standard oncologic fashion, including dissection of the common iliac, external iliac, internal iliac, and obturator nodal basins bilaterally. In cases where metastatic lymph nodes are identified beyond these regions, the lymph node dissection may be extended to achieve gross resection of involved nodal disease within the abdomen or retroperitoneum.

Timeline

• Start date: 2025-11-26
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-07-02
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States