Gastric cancer
Conditions
Interventions
TS-1: 80-120mg/day 2 times/day, p.o., day1-28. One course takes 42 days. For one year from surgery. PSK: 3g/day 3 times/day(1g/time), p.o., daily. For one year including TS-1 holidays.
TS-1: 80
Sponsors
Faculty of Medicine, Kagawa University Department of Gastroenterological Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histological proven gastric cancer 2)Surgical operated by D2 lymphadenectomy and curability A or B 3)Clinical Stage 2 (except for T1) or stage 3 4)No liver metastasis, peritoneal metastasis or distant metastasis and peritoneal washing cytology negative 5)Age 20-80 years 6)No pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery 7)Capable of oral administration within 6 weeks after surgery 8)Clear to the criteria as below Leukocyte: >LLN or 4,000/mm3 Blood platelet count: >10*104/mm3 Total bilirubin: <1.5mg/dl AST(GOT) ALT(GPT): <LLN*2.5 Serum creatinine: <LLN 9)Judged to be capable of tolerating this treatment, and who have given written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1)Schronous, mtaschronous double cancer/ multiple cancer 2)administration contraindication of TS-1 (refer package insert) 3)Regular use of flucytosine, phenytoin or warfarin potassium 4)History of severe drug allergy (grade 3>=) 5)Severe complications such as paralytic ileus, bowel obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure and hepatic failure etc. 6)Severe watery diarrhea 7)Pregnancy or lactation 8)Male intension that get with child 9)HIV positive 10)Patients who are recognized as inadequate patients by doctors whit responsibility in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events rate after starting chemotherapy (number of adverse event cases /number of enrolled cases) | — |
Secondary
| Measure | Time frame |
|---|---|
| TS-1 compliance (number of therapy completion courses/number of therapeutic plan courses) Quality of Life | — |
Countries
Japan
Contacts
Public ContactUsuki Hisashi
Faculty of Medicine, Kagawa University Department of Gastroenterological Surgery
Outcome results
None listed