EUS-RFA PANCARDINAL-1 Trial

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 - 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 of 0-2

Exclusion Criteria

  • Male or female patients < 18 years of age - 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

ArmDescriptionAssigned Intervention
Experimental
Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)
  • Device: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)
    Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) consists of the application of an alternating current with a frequency of 350-500 kilohertz (kHz) to the target tissue via a special electrode located at the tip of an echoendoscope. The alternating current causes the vibratory movement of ionic particles in the abutting and adjoining tissue and results in the generation of heat. However, RFA induces not only local disruption of the tumor by heat, but it also produces localized coagulation necrosis of the tumor; which induces the release of large amounts of cellular debris. This cellular debris represents a source of tumor antigens that can trigger a host adaptive immune response against the tumor.
  • Drug: Neoadjuvant Chemotherapy (NAC)
    The NAC regimen will be determined clinically by the participant's physician [possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)].

Recruiting Locations

Memorial Hermann Hospital
Houston, Texas 77030
Contact:
Nirav Thosani, MD
713-486-1350
pancreasresearch@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Sofia C Colon, BS
713-500-6658
Sofia.C.Colon@uth.tmc.edu