Advanced or recurrent gastric cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Unresectable advanced or recurrent gastric carcinoma which was confirmed histologically 2. negative or non-measurement of HER2 3. Patient with the measurable lesion 4. 76 years or older 5. ECOG performance status: 0-2 6. Chemo-naive patient 7. Sufficient organ functions in laboratory data within 14 days before enrollment 8. Possible of oral ingestion 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity for S-1 or ingredients of S-1 2. Patient who takes flucytosine, or phenytoin 3. Severe bone marrow suppression, severe renal dysfunction, or severe liver dysfunction 4. Severe concomitant disease (congestive heart failure, hemorrhagic peptic ulcer, ileus, symptomatic ischemic heart disease, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or etc) 5. Patient who suffered from myocardial infarction or cerebral infarction within six months 6. symptomatic brain metastasis 7. Severe mental disorders 8. Active synchronous malignancy 9. Watery diarrhea 10. HBV carrier who has to take nucleotide analogues (e.g. Entecavir) during chemotherapy 11. Patient who is judged inappropriate for the entry into this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Countries
Japan
Contacts
Kitasato University School of Medicine Department of Gastroenterology