Pancreatic Cancer Clinical Trial
Official title:
A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining radiation therapy with chemotherapy may kill more
tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
radiation therapy in treating patients who have locally advanced pancreatic cancer.
OBJECTIVES:
- Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year
survival, in patients with locally advanced pancreatic cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive
gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the
first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy,
patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats
every 28 days for a total of 3 courses in the absence of disease progression or unacceptable
toxicity.
Quality of life is assessed at baseline, at completion of radiotherapy, at completion of
chemotherapy, and 3 months after completion of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28
months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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