NCT04990609PHASE2Recruiting

EUS-RFA PANCARDINAL-1 Trial

The University of Texas Health Science Center, Houston

Start Date

8/13/2021

Completion Date

5/30/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

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

DRUG

Neoadjuvant Chemotherapy (NAC)

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Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Locations

Memorial Hermann Hospital

Houston, Texas 77030

United States