EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemotherapy, Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA).
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase I Pilot Study of Endoscopic Ultrasound Guided RFA in Advanced Pancreatic Cancer
Overview
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.
Interventions
- 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.
Primary outcome measures
- Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0 [Time frame: Up to Week 15]
Secondary outcome measures (5)
- Percentage of Participants who Complete all 3 EUS-RFA Treatments [Time frame: Up to Week 11]
- Disease-Free Survival from Diagnosis [Time frame: Up to Week 24]
- Disease-Free Survival from First Study Procedure [Time frame: Up to Week 24]
- Overall Survival From Diagnosis [Time frame: Up to Week 24]
- Percentage of Participants who Report Post-Procedural Complications [Time frame: Up to Week 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Tisch Hospital — New York
Identifiers
NCT: NCT05723107 · 22-00249