Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
- Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and
cisplatin in patients with stage IV gastric adenocarcinoma.
- Determine the overall survival of patients treated with this regimen.
- Determine the time to progression and types of initial recurrence in patients treated
with this regimen.
- Determine tumor response in patients treated with this regimen.
- Determine mortality and morbidity related to treatment in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive 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 or unacceptable
toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government