Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Radical cystectomy
Procedure/SurgeryThe 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Radical cystectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 month post-surgerySecondary outcomes
1
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.
Time frame
Assessed 30 days and 90 days post-surgery2
Frequency of 30-Day Postoperative Complications in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
This secondary outcome measure focuses on evaluating the incidence and severity of postoperative complications occurring within 30 days following surgical resection or multi-dose radiotherapy (MDRT) in participants with locally advanced or oligo-metastatic urothelial carcinoma. The assessment will be conducted using the Clavien-Dindo classification system, which categorizes surgical complications based on the intervention required for management. The goal is to understand the short-term impacts of the treatment on patient recovery and ensure that potential risks are clearly identified and managed.
Time frame
30 days post-surgery3
Changes in EORTC QLQ-C30 Global Health Status / Quality of Life (GHS/QoL) Subscale Scores Pre- and Post-Intervention Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
This outcome measure evaluates changes in quality of life using the EORTC QLQ-C30 Global Health Status / Quality of Life (GHS/QoL) subscale. The primary endpoint is the change in GHS/QoL subscale scores from pre-intervention to post-intervention. The scores will be analyzed to determine if there is an improvement in the perceived global health and quality of life of the participants following the intervention.
Time frame
At screening, 30 days post-surgery, 180 days post-surgery then finally at 365 days post-surgery4
Correlation Between Circulating Tumor DNA (ctDNA) Levels and Disease Recurrence Following Local Therapy in Patients with Locally Advanced/Oligo-Metastatic Urothelial Carcinoma
This secondary outcome measure aims to evaluate the correlation between circulating tumor DNA (ctDNA) levels and disease recurrence in participants with locally advanced or oligo-metastatic urothelial carcinoma (UC) following local therapy, including surgical resection or multi-dose radiotherapy (MDRT). The assessment will involve: Changes in ctDNA Status and Quantification: Measuring ctDNA levels at baseline (pre-intervention) and at specified intervals post-intervention to observe changes over time. This includes quantifying the concentration of ctDNA in blood samples using advanced molecular techniques. Correlation with Disease Recurrence: Analyzing the relationship between ctDNA levels and disease recurrence rates. This will involve comparing ctDNA concentrations with clinical outcomes to determine if changes in ctDNA levels can serve as a predictive biomarker for disease recurrence after local therapy.
Time frame
At screening then at 30, 90, 180, 270 and 365 days post-surgerySponsors and contacts
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Source ClinicalTrials.gov