Stage III (the 14th edition of staging system of Japanese Classification of Gastric Carcinoma) gastric cancer based on pathological findings after curative resection.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with histologically proved adenocarcinoma of advanced gastric cancer and esophagogastric junction. 2) Patients after curative resection of gastric cancer, and was diagnosed stage III (14th staging system of Japanese Gastric Cancer Association). 3) Age: 20-75. 4) ECOG performance status 0-1. 5) Patients with adequate bone marrow reserve (neutrophil count >=1500/mm3, hemoglobin level >= 8.0 g/dL, platelet count >= 100,000/mm3), adequate liver function (AST and ALT <= 100 IU/L, total bilirubin <= 1.5 mg/dL), kidney function (serum creatinine <=1.5 mg/dL). 6) Patients who can intake orally. 7) Written informed consent obtained from patients.
Exclusion criteria
Exclusion criteria: 1) Patients who received surgery within 2 weeks before enrollment. 2) Patients with uncontrable diabetis. 3) Patients who has past history of myocardial infarction within 6 months before enrollment or who has unstable angina. 4) Patients who receive anti-arrhythmia drug (except warfarin for atrial fibrillation). 5) Patients with liver chirrosis. 6) Patients with severe renal failure. 7) Patients with ileus or subileus. 8) Patients who receive continuous corticosteroid administration. 9) Patients with active infections. 10) Patients with uncontrollable ascites, pleural effusion or pericardial effusion. 11) Patients with a history of serious drug allergy. 12) Patients with grade 2-4 diarrhea based on CTCAE ver 4. 13) Patients with interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. Pregnant or lactating female. 14) Patients with grade 2-4 neuropathy based on CTCAE ver 4. 15) Patients who recieved transfusion within 2 weeks before enrollment, or has active bleeding. 16) Pregnant or lactating female. 17) Other patients evaluated to be inadequate to participate in this study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of accomplishing three cycles S-1+CDDP therapy | — |
Countries
Japan
Contacts
Toranomon Hospital Department of Medical Oncology