A PHASE II TRIAL OF NEOADJUVANT CISPLATIN-FLUOROURACIL CHEMOTHERAPY, SURGERY, AND INTRAPERITONEAL (IP) FLOXURIDINE (FUdR) PLUS LEUCOVORIN IN PATIENTS WITH GASTRIC CANCER
OBJECTIVES: I. Evaluate the efficacy and toxicity of neoadjuvant cisplatin/fluorouracil
(CDDP/5-FU) followed by surgery followed by adjuvant intraperitoneal floxuridine/leucovorin
in patients with high-risk gastric cancer. II. Assess the quality of life and cost-benefit
ratio associated with this treatment. III. Evaluate the sensitivity, specificity, and
overall staging accuracy of laparoscopy with or without laparoscopic ultrasound in
predicting the resectability rate (with and without neoadjuvant CDDP/5-FU), response to
chemotherapy, and accuracy when compared to pathologic findings. IV. Correlate the presence
of mutated vs. wild-type p53 suppressor oncogenes in endoscopic biopsies and resected tumor
specimens with clinical outcome (defined as downstaging, failure pattern, and disease-free
and overall survival) in patients treated with and without neoadjuvant CDDP/5-FU.
OUTLINE: The following acronyms are used: CDDP Cisplatin, NSC-119875 CF Leucovorin calcium,
NSC-3590 5-FU Fluorouracil, NSC-19893 FUDR Floxuridine, NSC-27640 2-Drug Combination
Chemotherapy followed by Surgery followed by Single-Agent Chemotherapy with Drug Modulation.
CDDP/5-FU; followed by total or subtotal radical gastrectomy with D2 dissection; followed by
FUDR; with CF.
PROJECTED ACCRUAL: A total of 50 patients will be entered over 2-2.5 years.
Primary Purpose: Treatment
David Paul Kelsen, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|