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Trial Title:
EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
NCT ID:
NCT05723107
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Patients will receive continuation of second or initiate third-line chemotherapy regimen
at the discretion and decision of treating oncologist.
Arm group label:
Chemotherapy plus EUS-RFA
Intervention type:
Device
Intervention name:
Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)
Description:
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.
Arm group label:
Chemotherapy plus EUS-RFA
Other name:
EUSRA RF Electrode
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tisch Hospital
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tamas A. Gonda, MD
Phone:
212-263-3095
Email:
Tamas.Gonda@nyulangone.org
Start date:
March 31, 2023
Completion date:
March 2026
Lead sponsor:
Agency:
NYU Langone Health
Agency class:
Other
Collaborator:
Agency:
Taewoong Medical
Agency class:
Other
Source:
NYU Langone Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05723107
