A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the pancreas

- Stage T1-4, N0-1 (stage I-IVA)

- No M1 or NX staging

- Primary tumor of the pancreas (pancreatic head, neck, uncinate process, or
body/tail) and maximum diameter/dimension and tumor status at surgical margin
known

- Prior potentially curative gross resection within 3-8 weeks before study

- No non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas,
cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile
duct carcinoma, or ampullary carcinoma

- No recurrent disease

- Post-resection CA-19-9 level required

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

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

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- No significant nausea or vomiting

- No prior malignancy within the past 5 years except nonmelanomatous skin cancer or
carcinoma in situ of the cervix

- Able to maintain adequate nutrition (at least 1,500 calories/day)

- Feeding tube allowed

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- See Disease Characteristics