gastric cancer
Conditions
Interventions
S-1: 80mg/m2 twice a day on days1-14 in 3 weeks Trastuzumab:8mg/kg(1st cycle)/6mg/kg(2nd cycle-) div. on day1 Oxaliplatin: 130mg/m2 div. on day1
Sponsors
Cancer Institute Hospital Japanese Foundation For Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histrologically proven advanced/recurrence adenocarcinoma 2)no prior therapy for gastric cancer except for adjuvant chemotherapy of S-1 which was finished more than 6 months ago 3)with measurable lesions by RECIST version 1.1 4)HER2 positve(IHC 3+ or IHC2+ and ISH+) 5)Age 20-75 6)ECOG PS 0 or 1 7)no symptomatic cerebral lesions 8)adequate organ functions(according to the labo-data which was taken within 2weeks before registration) 1. WBC =>3,000/mm3 2.neutrophil=>1,500/mm3 3.platelet=>100,000/mm3 4.AST=<100 IU/l 5.ALT=<100 IU/l 6.Total bililubin =<1.5 mg/dl 7. Creatinine=<1.2mg/dl 8. Creatinine clearance=>60ml/min 9) LVEF(Left Ventricular Ejection Fraction) >50% within 4weeks before registration 10) no abnormal findings in ECG within 4weeks before registration 11) possible for oral intake 12) with an expected survival longer than 3 months 13) with written Informed Consent
Exclusion criteria
Exclusion criteria: 1) could not administrate S-1,Oxaliplatin,and Trastuzumab 2)pregnant and/or nursing women or men who wish to have children in future 3)with actuve infectious disease 4)HBs antigen positive 5)with a histroy or current symptoms of heart failure, uncontrollable arrhythmia,angina pectoris,valvular disease,and uncontrollable hypertension 6)with interstitial pneumonia, pulmonary fibrosis, heart hailure, renal failure, hepatic failure, uncontrollable diabetes mellitus 7)with dyspnea at rest 8)with active bleeding from gastric cancer/ulcer 9)with severe diarrhea(over 4 times a day or watery diarrhea) 10)with severe sensory neuropathy 11)with active double cancers excluding carcinoma in situ and/or prior curative cancer with relapse free for more than 5 years 12)under meditation of flucytosine, phenytoin,or warfarin 13) under continuous meditation of steroids 14)judged to be unfit to participate in this study by investigater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival,Overall survival, Safety | — |
Countries
Japan
Contacts
Public ContactDasiuke Takahari
Cancer Institute Hospital gastroenterology
Outcome results
None listed