Pancreatic Cancer Clinical Trial
Official title:
Phase II Chemoradiation Trial Using Gemcitabine in Patients With Locoregional Adenocarcinoma of the Pancreas
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 gemcitabine plus radiation therapy in
treating patients with pancreatic cancer that cannot be removed surgically.
OBJECTIVES: I. Estimate time to progression and overall survival of patients with
locoregional adenocarcinoma of the pancreas treated with gemcitabine combined with radiation
therapy. II. Estimate the biomarker response to this regimen through evaluation of
circulating CA19-9 levels and correlate this response with survival of this patient
population.
OUTLINE: Patients receive radiation therapy 5 days per week for 5 1/2 weeks and gemcitabine
IV over 30 minutes not greater than 2 hours prior to radiation therapy twice weekly. This
combination radiation therapy and chemotherapy is followed by 2 weeks of rest. Patients with
stable or responding disease receive a higher dose of gemcitabine IV over 30 minutes weekly
for 3 weeks followed by 1 week of rest. This 4 week course is repeated 3 more times for a
total of 16 weeks of gemcitabine therapy alone. Patients are followed every 2 months for the
first year and then every 3 months for the next 2 years or until disease progression. Upon
documentation of disease progression, patients are followed every 3 months for survival and
secondary malignancy.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 24 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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