Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for pancreatic cancer.
  PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have undergone surgery.

Detailed description: OBJECTIVES:
  -  Compare the overall and disease-free survival of patients with resected adenocarcinoma of the pancreas treated with adjuvant fluorouracil-based chemoradiotherapy preceded and followed by fluorouracil vs gemcitabine.
  -  Compare the local-regional and distant disease control in patients treated with these regimens.
  -  Compare the acute and late toxic effects of these regimens in these patients.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal involvement (yes vs no), tumor diameter (less than 3 cm vs 3 cm or greater), and surgical margins (negative vs positive vs unknown). Patients are randomized to one of two treatment arms.
  -  Arm I: Beginning 3-8 weeks after definitive surgical resection, patients receive fluorouracil IV continuously for 3 weeks. Beginning 1-2 weeks later, patients receive fluorouracil IV continuously concurrently with radiotherapy 5 days a week for 5.5 weeks. Beginning 3-5 weeks after completion of chemoradiotherapy, patients receive fluorouracil IV continuously for 4 weeks every 6 weeks for 2 courses.
  -  Arm II: Beginning 3-8 weeks after definitive surgical resection, patients receive gemcitabine IV once weekly for 3 weeks. Beginning 1-2 weeks later, patients receive chemoradiotherapy as in arm I. Beginning 3-5 weeks after completion of chemoradiotherapy, patients receive gemcitabine IV once weekly for 3 weeks every 4 weeks for 3 courses.
  Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 518 patients will be accrued for this study within 8.6 years.

Eligibility: 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

Relevance to patient case: not relevant