gastric cancer
Conditions
Interventions
S-1:80mg/m2 or 100mg/m2 or 120mg/m2 twice a day on days 1-14 in 3 weeks L-OHP:130mg/m2 intravenous injection on day1 Trastuzumab:8mg/kg(1st cycle) or 6mg/kg(after 2nd cycle) intravenous injection o
Sponsors
Dokkyo Medical University Saitama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histopathologically proven advanced / recurrence gastric adenocarcinoma 2)Have measurable lesions by RECIST version 1.1 3)Positive for HER2 (IHC 3+ or IHC2+/FISH+) 4)Age 20-75 5)ECOG PS 0 or 1 6)No previous therapy for gastric cancer except for adjuvant chemotherapy which was finished more than 6 months 7)Neither ascites nor pleural effusion 8)No symptomatic cerebral lesions 9)Adequate organ functions (according to the hematologic test which was taken within 2 weeks before registration) WBC => 3,500/mm3 and =< 12,000/mm3 Neutrophil => 2,000/mm3 Platelet => 100,000/mm3 Hemoglobin => 9.0g/dL AST and ALT =< 100 IU/L Total bilirubin =< 1.5 mg/dL Creatinine =< 1.2mg/dL Creatinine clearance => 60ml/min 10)LVEF (Left Ventricular Ejection Fraction) >50% within 3 weeks before registration 11)No abnormal findings in ECG within 3 weeks before registration 12)Possible for oral ingestion 13)With an expectation of survival more than 3 months 14)With written Informed Consent
Exclusion criteria
Exclusion criteria: 1) Who cannot administrate TS-1, L-OHP and Trastuzumab 2)Pregnant and / or nursing women or men who wish to have children in future 3)With active infectious disease 4)Positive for HBs antigen 5)Have a history or current symptoms of heart failure, uncontrollable arrhythmia, angina pectoris, valvular disease and uncontrollable hypertension 6)With interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure and uncontrollable diabetes mellitus 7)With dyspnea at rest 8)With active bleeding from gastric cancer or ulcer 9)With severe diarrhea (over 4 times a day or watery diarrhea) 10)With active double cancers excluding carcinoma in situ and / or prior curative cancer with relapse free for more than 5 years 11)Under medication of flucytosine or phenytoin,or warfarin 13)Under continuous medication of steroids 14)Judged to be unfit for this study by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence and extent of adverse events, progression-free survival, overall survival, time to treatment failure | — |
Countries
Japan
Contacts
Public ContactMitsui Takashi
Dokkyo Medical University Saitama Medical Center Department of Surgery
Outcome results
None listed