Gastric Cancer
Conditions
Interventions
TS-1 orally in 2 divided doses for 2weeks on and 1week rest trastuzumab intravenously on day1 of every 3weeks
Sponsors
Shimane University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease 2) Positive HER2 status 3) Lesions confirmed on imaging within 28 days before registration 4) No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy 5) ECOG Performance Status of 0 to 2 6) Adequate Major organ functions within 14 days before registration 7) Life expectancy of at least 3 months after registration 8) Written informed consent 9) Age of 20 to 74 years with either gender
Exclusion criteria
Exclusion criteria: 1) Past history of drug allergy 2) Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 3) R1 operation(histlogically positive PM, OM, LM, VM ) 4) Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium 5) Patient with clinically obvious infecton 6) Past history of drug allergy of S-1, CDDP and Trastuzumab 7) Heart disease that is serious or requires hospitalization, or history of such disease within past year 8) Chronic diarrhea (watery stool or 4 times or more/day) 9) Massive ascites 10) Multiple bone metastasis 11) Clinical suspicion or previous history of metastasis to brain or meninges 12) Operation within 28day 13) More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment. 14,15) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage 16) requiring steroid drug 17) Active hepatitis type HBs positive 18) Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Response rate Adverse event | — |
Countries
Japan
Contacts
Public ContactNoriyuki Hirahara, M.D., Ph.D.
Shimane University Hospital Digestive and General Surgery
Outcome results
None listed