Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
- Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally
advanced gastric cancer.
- Determine the histological response in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine postoperative morbidity in patients treated with this regimen.
- Determine the rate of potentially curative surgery in patients treated with this
OUTLINE: This is a multicenter study.
Patients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15.
Treatment repeats every 28 days for 2 courses in the absence of disease progression or
unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After
surgery, patients resume treatment with S-1 alone as before for 1 year.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Mitsukazu Gotoh, MD
Fukushima Medical University Hospital
United States: Federal Government