Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer

Inclusion Criteria:

• Patients must have histologically or cytologically-confirmed pancreaticadenocarcinoma.

• Patients must have non-metastatic pancreatic cancer not appropriate for immediatesurgical resection. This includes the following:

• Any involvement (defined as loss of fat plane on contrast CT) of any of thefollowing vessels*:

• Common hepatic artery

• Superior mesenteric artery

• Celiac axis

• Superior mesenteric vein

• Portal vein

• Aorta

• These criteria will be judged by the operating surgeon in conjunctionwith a radiologist prior to enrollment.

• Poor performance status not immediately conducive to radical surgery

• Other clinical reasoning by the treating physicians that supports pre-operativechemoradiation

• Patients must have evaluable disease as measured by RECIST 1.1 criteria.

• Planned surgical resection at the time of enrollment (may be initially staged asresectable, borderline resectable, or locally-advanced/unresectable).

• Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.

• Adequate bone marrow, hepatic, renal function.

• ANC ³ 1,500/ml and PLT ³ 100,000/ml

• Bilirubin less than 1.5 ULN

• AST and ALT < 3X ULN

• Serum Creatinine <1.5X ULN

• Prior chemotherapy allowed, but not mandatory. Patients who have undergonechemotherapy prior to participating in this study must have had a 2 week washoutperiod at the time of signing the consent form.

• Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration. Postmenopausal woman must have been amenorrheic andnonlactating for at least 12 months to be considered of non-childbearing potential.Men and women of child bearing potential must be willing to exercise an effectiveform of birth control (abstinence/contraception) while on study and for 3 monthsafter therapy is completed. Please refer to section 6.4 for additional detail.

• Age > 18 years

• Participants must sign a written informed consent and HIPAA consent prior toperformance of study-specific procedures or assessments and must be willing tocomply with treatment and follow up.

Exclusion Criteria:

• Radiological or cytologically confirmed metastatic disease

• Patients who have had any prior therapy for pancreatic cancer, except chemotherapy (see 6.1.7)

• Concurrent non-study chemotherapy or biologic therapy

• A history of ataxia telangiectasia or other documented history of radiationhypersensitivity

• Scleroderma or active connective tissue disease

• Active inflammatory bowel disease

• Serious, active infections requiring treatment with IV antibiotics

• Uncontrolled intercurrent illness including, but not limited to, psychiatricillness/social situations that would limit compliance with study requirements.