Trial Information

A Phase II Trial of Neoadjuvant Cisplatin - Fluorouracil Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer

OBJECTIVES: I. Evaluate the tolerability and toxic effects of neoadjuvant cisplatin plus
paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin
calcium in patients with high-risk gastric cancer. II. Assess the pathologic response of
gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy, and preliminarily
assess the patterns of failure and disease free and overall survival.

OUTLINE: Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1
every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour
intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal
on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin
calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first
4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for
5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin
calcium for 5 days 4-6 weeks after completing radiation treatment. Patients are followed
every month for the first 3 months, every 3 months for the next 21 months, every 6 months
for the next year, and annually thereafter.

PROJECTED ACCRUAL: Approximately 30-42 patients will be accrued over 18 months.