Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.

Inclusion criteria

• • Subject signed inform consent

• Age > 18 years
• Not pregnant or breast feeding
• Patient capable of undergoing anesthesia
• Patient selected to undergo Whipple procedure or distal pancreatectomy
• Patient does not have metastatic disease
• Patients will have close margins
• No prior radiation therapy to the region for separate cancer
• Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
• Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
• Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
• Gemcitabine + nb-paclitaxel
• FOLFIRINOX
• Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
• up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil

Exclusion criteria

• Not surgical candidate
• Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
• An IRE candidate (IRE is Percutaneous irreversible electroporation)
• Recurrent or previously resected tumors
• Documented History of Alcoholism and or drug abuse
• Participant in other clinical trials