Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patient must be > 18 years of age.
Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days prior to registration.

Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the pancreas according to the American Joint Committee on Cancer (AJCC) staging system.

NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report Shuttle CRF.
Patient must have undergone a potentially curative gross total resection by pancreaticoduodenectomy (includes R0 [no residual tumor] or R1 [microscopic residual tumor]) within 56 days prior to beginning treatment. NOTE: The operative report must be submitted to ACOSOG on the Operative Report Shuttle CRF.

Patient must have stable or increasing weight in the 14 days prior to the start of treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must be initiated prior to the start of treatment.6. Patient must have adequate bone marrow, hepatic and renal function, within 7 days prior to registration:

WBC > 3,000 mm^3
ANC > 1,500 mm^3
hemoglobin > 9.5 mg/dl
platelet count > 100,000 mm^3
total bilirubin < 3 mg/dl
AST (SGOT) < 2.0 times institutional upper limit of normal (ULN)
ALT (SGPT) < 2.0 times institutional ULN
alkaline phosphatase < 2.0 times institutional ULN
serum creatinine < 1.5 times institutional ULN

7. Patient must have a baseline diagnostic CT scan of the chest and CT scan with IV contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration, to exclude metastatic disease.

8. If female of childbearing potential, patient must have a negative urine or serum pregnancy test, within 7 days prior to registration. NOTE: Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered not of childbearing potential.

9. Patient (male or female) of reproductive potential must agree to use medically acceptable contraception during the study. NOTE: Medically acceptable contraceptives include: (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).

10. Patient, or the patient's legally acceptable representative, must sign and date an informed consent PRIOR to registration and the performance of any study related procedures.

11. Patient, or the patient's legally acceptable representative, must provide written authorization to allow the use and disclosure of their protected health information.

- NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.

12. If patient is a cancer survivor, all of the following criteria must be met and documented in the patient's medical record:

Patient has undergone potentially curative therapy for all prior malignancies.
No evidence of prior malignancies for at least 5 years (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer).
No evidence of recurrence of any prior malignancy.

Exclusion Criteria:

Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma.
Patient is pregnant or lactating.
Patient has recurrent pancreatic cancer.
Patient has received prior systemic chemotherapy or radiotherapy for pancreatic cancer.
Patient has received external beam photon (x-ray) therapy to the chest, abdomen or pelvis.
Patient has received any biologic/ immunologic therapies.
Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality.
Patient has a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorders.