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Table 2 Eligibility criteria

From: Neoadjuvant docetaxel, oxaliplatin and S-1 therapy for the patients with large type 3 or type 4 gastric cancer (OGSG1902): protocol of a multi-center, phase II study

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
  1. CT computed tomography, ECOG Eastern Cooperative Oncology Group, AST Aspartate Aminotransferase, GOT Glutamic Oxaloacetic Transaminase, ALT Alanine transaminase, GPT Glutamic Pyruvic Transaminase, HER2 human epidermal growth factor receptor 2. Clinicopathological findings of gastric cancer are written according the Japanese Classification of Gastric Carcinoma (15th edition)