Esophageal Cancer Clinical Trial
Official title:
RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not known whether chemotherapy before surgery is more
effective than surgery alone in treating cancer of the esophagus.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without
chemotherapy in treating patients with stage II or stage III cancer of the esophagus.
OBJECTIVES: I. Compare resectability and survival in patients with stage II/III esophageal
cancer treated with neoadjuvant cisplatin/fluorouracil vs. surgery alone.
OUTLINE: This is a randomized study. Patients are randomized to one of two groups. The first
group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by
esophagectomy and regional lymphadenectomy. The second group undergoes esophagectomy and
regional lymphadenectomy alone. All patients are followed for survival.
PROJECTED ACCRUAL: A total of 240 patients will be entered over 4 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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