Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer

This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.

Inclusion criteria

• Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
• CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration
• CT chest or PET/CT within 6 weeks prior to registration
• Clinically determined to be resectable based on NCCN Criteria:
• No radiographic evidence of superior mesenteric vein or portal vein distortion
• No evidence of distant metastasis
• Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
• No enlarged lymph nodes per CT criteria or PET avid lymph nodes
• No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)
• Adequate cardiopulmonary reserves to tolerate surgery
• Karnofsky performance status > 70
• Age >18
• Adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) > 1800 cells/mm3
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8 g/dl is acceptable.)
• Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry
• Patient must sign study specific informed consent prior to study entry

Exclusion criteria

• Prior surgical resection of any pancreatic malignancy
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
• Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Severe, active comorbidity, defined as follows:

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.
• Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
• Any evidence of distant metastases (M1)
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic