Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas

OBJECTIVES:

• Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy.

OUTLINE: Patients are randomized to undergo standard pancreatoduodenectomy (PD) or PD with extended lymph node resection after an exploratory laparotomy.

Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery, if no metastases are evident. Radiation therapy is given every week for 5 weeks. Fluorouracil/leucovorin calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of week 1 and days 29-31 of week 5.

Patients are followed every 4 months for the first year, then every 6 months for the next 2 years.

PROJECTED ACCRUAL: 50 patients will be accrued per group for a total of 100 patients.

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven adenocarcinoma of the exocrine pancreas excluding periampullary cancer
• Resectable malignancy must be located in a region that can be encompassed by a radiation port of 20 x 20 cm
• No evidence of extranodal metastatic disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Not specified

Renal:

• Bilateral renal function as demonstrated by excretory urogram (IVP) or abdominal CT scan with contrast OR
• Greater than 2/3 of one functioning kidney must be shielded during radiation therapy

Other:

• Must have adequate oral nutrition (greater than 1200 calories daily)
• Greater than 5 years since prior malignancy except:

• Squamous cell skin cancer
• Basal cell skin cancer
• In situ cervical cancer
• Not pregnant or lactating
• Patients of reproductive potential must use effective birth control
• No cystic neoplasms of the pancreas
• No islet cell, periampullary or cholangiocarcinoma
• No Federal Medical Center inmates

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for this disease

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiation therapy for this disease
• No prior radiation therapy to the abdomen

Surgery:

• Celiotomy and standardized exploration for resectability required