EUS-RFA PANCARDINAL-1 Trial

The University of Texas System (UT)

Status and phase: Enrolling; Phase 2

Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)

Treatments: Drug: Neoadjuvant Chemotherapy (NAC); Device: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04990609

HSC-MS-21-0066

R01CA277161-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)

Experimental group

Treatment:

Device: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)

Drug: Neoadjuvant Chemotherapy (NAC)