Gastric neoplasm
Conditions
Interventions
S-1: 40mg/m2 PO bid (morning and evening) for 4 weeks with 2 weeks rest In total of 1 year after surgery
S-1: 40mg/m2 PO bid (morning and evening) for 4 weeks with 2 weeks rest Lafutidine: 10mg/bod
Sponsors
Pharma Valley Center , Shizuoka Industrial Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological proven gastric carcinoma 2) D>=2 lymph node dissection and curability A or B 3) Stage II/III (except for T1) 4) Patient with negative peritoneal washing cytology 5) Age 20-80 years 6) No prior treatment without surgery 7) Patient can start administration of S-1 within 8 weeks after surgery. 8) Adequate organ functions defined as indicated below (1)WBC >= 4,000 /mm3 , WBC <= 12,000 /mm3 (2)neutrophil >= 1,500 /mm3 (3)Plt >= 100,000 /mm3 (4) T.Bil <= 1.5 mg/dL (5) AST(GOT) , ALT(GPT) <= 100 IU/L (6) Cr < 1.5 mg/dL (7) Ccr >= 60 mL/min/body 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patient with active double cancer (synchronous double cancer and metachronous double cancer), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 2) Patient with administration contraindication of S-1 and Lafutidine 3) Patient with regular use of H2-blocker, PPI, furucytocin, fenytoin, or warfarin. 4) Patients with the past history of severe allergic reactions. 5) Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 6) Severe watery diarrhea. 7) pregnant or nursing patient or with intent to bear baby 8) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of S-1 treatment according to planned | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Toxicity 2) The relative total administration dose of S-1 | — |
Countries
Japan
Contacts
Public ContactKeisei Taku
Shizuoka General Hospital Div. of Medical Oncology, Shizuoka General Hospital
Outcome results
None listed