Gastric Cancer Clinical Trial
Official title:
Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Giving chemotherapy before surgery may shrink the tumor so that it can be completely
removed.
PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works
in treating patients who are undergoing surgery for locally advanced stomach cancer.
OBJECTIVES:
Primary
- Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally
advanced gastric cancer.
Secondary
- 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
regimen.
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
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