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

Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®

This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable 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.

Inclusion Criteria:

• Subject signed informed consent
• Age >/= 18 years
• Biopsy confirmed adenocarcinoma pancreatic cancer
• Patient capable of undergoing anesthesia
• Patient is a surgical candidate
• Patient selected to undergo pancreatic cancer resection
• Patient will have known or suspected close/positive surgical margin
• Confirmed diagnosis of resectable pancreatic adenocarcinoma
• Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle

Exclusion Criteria:

• Pregnant or breast feeding
• Patient has metastatic disease
• Patient has had prior radiation therapy to the region for separate cancer
• Patient has had prior chemotherapy
• Any other invasive cancer in the past 5 years, except basal cell skin
• Recurrent or previously resected tumors
• Alcoholism/Drug abuse