A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Locally advanced or regional (encompassable within the same radiotherapy
portals)

- Adenosquamous cancers are allowed

- Unresectable disease

- Measurable and/or non-measurable disease as determined by computed tomography (CT)
scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks
prior to randomization.

- Age>=18

- ECOG Performance status of 0-1

- Life expectancy >= 12 weeks

- Adequate bone marrow reserve,liver and renal function within 2 weeks of
randomization:

- Absolute granulocyte count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or
cholangitis)

- Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)

- Albumin greater than 2.5 g/dL

- Creatinine no greater than 1.5 times ULN

- Fertile patients must use effective contraception

- Willing and able to attend follow-up visits

- Concurrent enrollment on protocol ECOG-E1Y03 allowed

- More than 4 weeks since prior investigational agents

Exclusion Criteria:

- Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)

- Stage M1 disease

- Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology

- Pregnant or nursing

- Active infection within within 4 weeks of randomization

- Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ
of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7)

- History of active collagen vascular disease (i.e., systemic lupus erythematosus,
rheumatoid arthritis, or scleroderma)

- Signs or symptoms of peptic or duodenal ulcer disease

- Concurrent serious systemic disorders that are incompatible with study participation

- Prior chemotherapy for pancreatic cancer

- Prior radiotherapy

- Concurrent intensity modulated radiotherapy