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.
Sponsors
Kansai Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological proven gastric cancer 2) Stage II (except for T1) or stage III 3) Onset of hematological or non-hematological grade 2>= adverse events within 1-3 course of TS-1 4) No liver metastasis, peritoneal metastasis or distant metastasis and peritoneal washing cytology negative 5) Age 20-80 years 6) No history of pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery 7) Written informed consent.
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 |
|---|---|
| grade 2>= adverse events rate after starting protocol therapy (TS-1 + PSK combination therapy) (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) | — |
Countries
Japan
Outcome results
None listed