Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
RATIONALE: Surgery to remove the pancreas, some of the small intestine, and lymph nodes may
 be more effective treatment for cancer of the pancreas than surgery to remove the pancreas
 and some of the small intestine alone. Radiation therapy uses high-energy x-rays to damage
 tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing
 so they stop growing or die. Combining surgery, radiation therapy, and chemotherapy may be an
 effective treatment for cancer of the pancreas.

 PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the
 pancreas and a portion of the small intestine with or without removing lymph nodes, 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