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 chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.
OBJECTIVES: * Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy. * Determine the time to progression in patients treated with this regimen. * Determine the overall clinical response in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 6 weeks. Three weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 24 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)
200mg/sq m IV infusion over 30 min wkly (on d 1, 2, OR 3) during radiation tx (wks 1-6) 1000mg/sq m IV infusion over 30 min wkly for 3 weeks during ea chemotherapy cycle
4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)
Overall Survival
Time frame: 9 months up to 3 years post treatment
Time to progression
Time frame: After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs
Clinical Response
Time frame: q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs
CA19-9 Levels
Biomarker response
Time frame: q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs
Toxicity
Time frame: q cycle
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