RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Ermanno Ancona, MD
Study Chair
Azienda Ospedaliera di Padova
United States: Federal Government
CDR0000065226
NCT00002897
July 1992
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