EUS-RFA PANCARDINAL-1 Trial

Summary

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.

Interventions

• Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) · DEVICE

  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.

• Neoadjuvant Chemotherapy (NAC) · DRUG

  The NAC regimen will be determined clinically by the participant's physician \[possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)\].

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Memorial Hermann Hospital, Houston, Texas · RECRUITING