EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

Pancreatic Cancer Clinical Trial

Official title:

Phase I Pilot Study of Endoscopic Ultrasound Guided RFA in Advanced Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723107
• Other study ID #: 22-00249
• Status: Recruiting
• Phase: Phase 1
• Start date: March 31, 2023
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Tamas A. Gonda, MD
• Phone: 212-263-3095
• Email: Tamas.Gonda[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single arm study in the treatment of pancreatic ductal adenocarcinoma (PDAC). The investigators propose to test the tolerability of chemotherapy plus endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using the RF Electrode in patients receiving palliative second or third line therapy for unresectable non-metastatic pancreatic cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed and histologically confirmed PDAC by biopsy
• Axial CT scan or MRI consistent with PDAC with at least 1 cm in greatest diameter
• ECOG performance status 0-2
• Patients with locally advanced PDAC, who have not responded or progressed on first line chemotherapy, are deemed not resectable based on multidisciplinary review, and show no evidence of distant metastasis
• Lesions between 1 - 4cm in size

Exclusion Criteria:

• Patients that show evidence of distant metastasis
• Endoscopically non-accessible mass
• Pregnant patients
• Inability to provide informed consent
• Lesions <1cm, or >4cm in greatest diameter

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Chemotherapy
Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.

Device:
• Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)
EUS-RFA will be delivered using the EUSRA RF Electrode, which is a sterile, single-use electrosurgical accessory for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator (VIVA Combo RF Generator). The device will be used during a routine EUS, which is a minimally invasive procedure used to assess gastrointestinal diseases. Each EUS-RFA procedure will last approximately 60 minutes.

Locations

Country	Name	City	State
United States	Tisch Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Taewoong Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0	Per Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0, Grade III AEs are defined as severe or medically significant but not immediately life-threatening; or hospitalization or prolongation of hospitalization indicated; or disabling; or limiting self care activities of daily living. Grade IV AEs are defined as life-threatening consequences; or urgent intervention indicated.	Up to Week 15
Secondary	Percentage of Participants who Complete all 3 EUS-RFA Treatments	Treatments delivered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11).	Up to Week 11
Secondary	Disease-Free Survival from Diagnosis	Time from diagnosis to first clinical evidence of local or distant recurrence.	Up to Week 24
Secondary	Disease-Free Survival from First Study Procedure	Time from first study procedure (delivered during Weeks 1-3) to first clinical evidence of local or distant recurrence.	Up to Week 24
Secondary	Overall Survival From Diagnosis	Time from diagnosis to death.	Up to Week 24
Secondary	Percentage of Participants who Report Post-Procedural Complications		Up to Week 24