• Objective response rate [ Designated as safety issue: No ]
• Progression-free survival [ Designated as safety issue: No ]
• Toxicity as measured by NCI CTC v2.0 [ Designated as safety issue: Yes ]
• Quality of life as measured by Functional Assessment of Cancer Treatment-Hepatobiliary Symptom Index at baseline, 6, 15, and 16 weeks, and at 9 months [ Designated as safety issue: No ]

• Objective response rate
• Progression-free survival
• Toxicity as measured by NCI CTC v2.0
• Quality of life as measured by Functional Assessment of Cancer Treatment-Hepatobiliary Symptom Index at baseline, 6, 15, and 16 weeks, and at 9 months

RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

OBJECTIVES:

• Compare the progression-free and overall survival of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy.
• Compare the objective response rate in patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.
• Compare the quality of life (QOL) of patients treated with these regimens.
• Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1) and weight loss within the past 6 months (less than 10% vs 10% or more). Patients are randomized to 1 of 2 treatment arms.

Arm I (Gemcitabine alone):

• Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest.
• Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Arm II (Gemcitabine with radiotherapy):

• Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1. Patients also undergo concurrent radiotherapy 5 days a week for 5.5 weeks beginning on day 1.
• Consolidation: Approximately 4 weeks after completion of radiotherapy, patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival.

PROJECTED ACCRUAL: Approximately 332 patients will be accrued for this study within 2 years.

• Drug: gemcitabine hydrochloride
• Radiation: radiation therapy

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

  • Locally advanced or regional (encompassable within the same radiotherapy portals) disease
  • No M1 disease
  • Adenosquamous cancers are allowed

• The following cellular types are not allowed:

  • Small cell
  • Mucinous cystadenocarcinoma
  • Islet cell
  • Papillary cystic neoplasms
• Unresectable disease, defined as a tumor causing superior mesenteric vein or portal vein occlusion OR superior mesenteric artery or hepatic artery encasement
• Must not be a candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)
• Measurable and/or nonmeasurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count at least 2,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)
• AST less than 5 times upper limit of normal (ULN)
• Albumin greater than 2.5 g/dL

Renal

• Creatinine no greater than 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Willing and able to attend follow-up visits
• Concurrent enrollment on protocol ECOG-E1Y03 allowed
• No active infection within the past 4 weeks
• No other 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)
• No history of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)
• No signs or symptoms of peptic or duodenal ulcer disease
• No concurrent serious systemic disorders that are incompatible with study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for pancreatic cancer

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy
• No concurrent intensity modulated radiotherapy

Surgery

• See Disease Characteristics

Other

• More than 4 weeks since prior investigational agents

• National Cancer Institute (NCI)
• Radiation Therapy Oncology Group