A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma
A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma
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:
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.
DISEASE CHARACTERISTICS:
Histologically confirmed pancreatic adenocarcinoma
Non-metastatic disease that is unresectable due to any of the following:
Measurable or evaluable disease
No prior therapy for pancreatic adenocarcinoma
No peritoneal seeding or other evidence of metastatic disease by laparotomy or laparoscopy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Los Angeles, California 90048, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20422, United States
Hollywood, Florida 33021, United States
Fort Wayne, Indiana 46885-5099, United States
Baltimore, Maryland 21201, United States
Boston, Massachusetts 02115, United States
Saint Joseph, Michigan 49085, United States
Columbia, Missouri 65203, United States
Omaha, Nebraska 68198-7680, United States
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East Syracuse, New York 13057, United States
Syracuse, New York 13210, United States
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