gemcitabine with or without radiation therapy in treating patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: 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 overall survival and progression-free 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 intravenously (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. accrual: 74 patients were accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the pancreas * locally advanced or regional (encompassable within the same radiotherapy portals) * adenosquamous cancers are allowed * unresectable disease * measurable and/or non-measurable disease as determined by computed tomography (ct) scan or magnetic resonance imaging (mri), which must be performed within 4 weeks prior to randomization. * age\>=18 * ecog performance status of 0-1 * life expectancy \>= 12 weeks * adequate bone marrow reserve,liver and renal function within 2 weeks of randomization: * absolute granulocyte count at least 2,000/mm\^3 * platelet count at least 100,000/mm\^3 * bilirubin less than 3 mg/dl (unless secondary to biliary obstruction or cholangitis) * serum glutamic-oxaloacetic (ast) less than 5 times upper limit of normal (uln) * albumin greater than 2.5 g/dl * creatinine no greater than 1.5 times uln * fertile patients must use effective contraception * willing and able to attend follow-up visits * concurrent enrollment on protocol ecog-e1y03 allowed * more than 4 weeks since prior investigational agents exclusion criteria: * candidate for surgical excision based on local extent of disease (e.g., t3, n1, m0) * stage m1 disease * small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology * pregnant or nursing * active infection within within 4 weeks of randomization * 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) * history of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma) * signs or symptoms of peptic or duodenal ulcer disease * concurrent serious systemic disorders that are incompatible with study participation * prior chemotherapy for pancreatic cancer * prior radiotherapy * concurrent intensity modulated radiotherapy

Keywords: stage iii pancreatic cancer adenocarcinoma of the pancreas