Pancreatic Cancer Clinical Trial
Official title:
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:
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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