A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer
A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer
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:
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):
Arm II (Gemcitabine with radiotherapy):
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.
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
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:
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:
Farmington, Connecticut 06030, United States
New Haven, Connecticut 06520-8032, United States
Valdosta, Georgia 31603, United States
Chicago, Illinois 60611, United States
Libertyville, Illinois 60048, United States
Skokie, Illinois 60076, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Sioux City, Iowa 51101, United States
West Des Moines, Iowa 50266, United States
Baltimore, Maryland 21287-8936, United States
Lambertville, Michigan 48144, United States
Saint Joseph, Michigan 49085, United States
Minneapolis, Minnesota 55403, United States
Robbinsdale, Minnesota 55422, United States
Columbia, Missouri 65203, United States
Flemington, New Jersey 08822, United States
Toms River, New Jersey 08755, United States
Cooperstown, New York 13326, United States
Greenville, North Carolina 27858, United States
Wilmington, North Carolina 28401, United States
Winston-Salem, North Carolina 27103, United States
Cleveland, Ohio 44106, United States
Youngstown, Ohio 44510, United States
Drexel Hill, Pennsylvania 19026, United States
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19107, United States
Pittsburgh, Pennsylvania 15213, United States
Sioux Falls, South Dakota 57104, United States
Knoxville, Tennessee 37920, United States
Seattle, Washington 98114, United States
Charleston, West Virginia 25304, United States
La Crosse, Wisconsin 54601, United States
Wausau, Wisconsin 54401, United States