Table 2 Eligibility criteria
Inclusion criteria | |
1) Histologically proven gastric cancer (common types) | |
2) Large type 3 (≥8 cm measured by CT or endoscopy) or type 4 | |
3) No peritoneal metastasis (CY0 or 1, and P0) by laparoscopy and CT within 28 days | |
4) No sign of distant metastasis including liver metastasis or paraaortic lymph node metastasis | |
5) Length of esophageal invasion ≤3 cm by image examination within 28 days | |
6) Age between 20 and 80 at registration | |
7) Performance status (ECOG) 0 or 1 | |
8) No prior treatment of chemotherapy or radiation therapy | |
9) Adequate organ function (bone marrow, heart, lungs, liver, kidneys, etc.) | |
10) Laboratory examination meet the following criteria (data within 14 days from the date of enrollment are used); neutrophils ≥1500 /mm3, platelet count ≥100,000 /mm3, hemoglobin ≥8.0 g/dL, (Blood transfusion must not be performed within 14 days before the blood sampling date of the test used for registration), AST (GOT) ≤100 IU/L, ALT (GPT) ≤100 IU/L, total bilirubin ≤2.0 mg/dL, and creatinine clearance ≥50 mL/min | |
11) Fair oral intake with or without bypass surgery | |
12) HER2 negative or not examined | |
13) Written informed consent from patient | |
Exclusion criteria | |
1) Synchronous or metachronous (within 5 years) malignancies | |
2) Infectious disease requiring systemic treatment (over 38.0 °C) | |
3) Women who are pregnant, may be pregnant, or breastfeeding, or men who want to get pregnant with their partners | |
4) Severe mental disease | |
5) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration | |
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment | |
7) Under treatment with flucytosine, phenytoin, or warfarin | |
8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy | |
9) Hepatitis B surface antigen positive | |
10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT | |
11) Poorly controlled hypertension or diabetes | |
12) Patients judged inappropriate for the study by the physicians |