Esophageal Cancer Clinical Trial
Official title:
Esophageal Cancer: A Phase II Study of Paclitaxel, Carboplatin and 5-Fluorouracil With Simultaneous Radiotherapy Followed by Surgical Resection
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.
Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that
it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation
therapy given before surgery in treating patients who have stage I, stage II, or stage III
esophageal cancer.
OBJECTIVES: I. Determine the total response rate in patients with stage I, II, or III
esophageal cancer treated with paclitaxel, carboplatin, and fluorouracil with concurrent
radiotherapy followed by surgical resection. II. Determine the overall survival of these
patients treated with this regimen. II. Determine the toxicity of this regimen in this
patient population.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30
minutes on days 1 and 22, and fluorouracil IV continuously on days 1-42. Patients undergo
radiotherapy concurrently with chemotherapy daily 5 days a week for 5 weeks. Patients then
undergo surgical resection within 3-5 weeks following completion of therapy. Patients are
followed every 3 months for 6 months, every 6 months for 1 year, and then annually
thereafter.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
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