Consolidative Local Therapy (CLT) in Oligo-metastatic Uro... | NCT07048457

NCT07048457

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Medical College of Virginia Foundation	UNKNOWN

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radical cystectomy	Experimental	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.	Procedure: Radical cystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radical cystectomy	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
12-Month Progression-Free Survival in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma	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.	12 month post-surgery

Secondary Outcomes

Measure	Description	Time Frame
Frequency of Treatment-Related Adverse Events in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma	This secondary outcome measure focuses on assessing the frequency and severity of treatment-related adverse events (AEs) in participants with locally advanced or oligo-metastatic urothelial carcinoma (UC) undergoing consolidative therapy. This assessment will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 to document the type, frequency, and grade of AEs reported by participants during and after the treatment period. The aim is to comprehensively evaluate the safety and tolerability of the consolidative therapy.

Eligibility Module

Eligibility Criteria

Inclusion 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:
1. Hgb >9.0 ng/dL.
2. WBC >3.0 K/mcL.
3. PLT >100 K /mcL.
4. AST <3.0 x ULN U/L.
5. ALT <3.0 x ULN U/L.
6. 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 start of the first cycle. 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.

Exclusion Criteria:

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 examinations.
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.

ID	Term
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative