A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer
Purpose
The objectives of this study are to determine the feasibility, tolerability, and treatment effect of Endoscopic Ultrasound (EUS) Radiofrequency ablation (RFA) plus standard-of-care Neoadjuvant chemotherapy (NAC) in the treatment of Pancreatic Ductal Adenocarcinoma (PDAC). Endoscopic Ultrasound (EUS) Radiofrequency ablation (RFA) and Neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.
Condition
- Pancreatic Ductal Adenocarcinoma (PDAC)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosed and histologically confirmed PDAC by biopsy - Permanent street address and consent to study participation - Axial CT scan consistent with PDAC - No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria
- No phone number of Male or Female patients > 18 years of age - Diagnosed and histologically confirmed PDAC by biopsy - No permanent street address or telephone number - Pregnant patients - Inmates or prisoners - Unable to provide informed consent
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Neoadjuvant chemotherapy (NAC) plus Endoscopic Ultrasound (EUS) Radiofrequency ablation (RFA) |
|
Recruiting Locations
Memorial Hermann Hospital
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center, Houston