Trial Information

Phase III Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Potentially Resectable Stage III Advanced Gastric Cancer

OBJECTIVES:

Primary

- Compare the overall survival of patients with potentially resectable stage III gastric
cancer treated with neoadjuvant S-1 and cisplatin followed by gastrectomy and adjuvant
S-1 vs no neoadjuvant chemotherapy before gastrectomy and adjuvant S-1.

Secondary

- Compare the progression-free survival of patients treated with these regimens.

- Compare the curative resection rates in patients treated with these regimens.

- Compare the safety of these regimens, in terms of postoperative complications, adverse
events, and treatment- or surgery-related mortality rate, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (T3 vs T4) and ECOG performance status (0 vs 1). Patients are randomized to 1
of 2 treatment arms.

- Arm I (control): Patients undergo gastrectomy with D2+ lymph node dissection. Patients
then receive adjuvant oral S-1.

- Arm II (neoadjuvant therapy): Patients receive neoadjuvant oral S-1 on days 1-21 and
cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in
the absence of disease progression. Patients then undergo surgery and receive adjuvant
S-1 as in arm I.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study.