untreated HER2 positive advanced gastric cancer
Conditions
Interventions
S-1+trastuzumab (S-1 80mg/m2 d1-28 and trastuzumab 8 or 6 mg/kg q3w)
Sponsors
Digestive Desease Support Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma 2) Without previous medication history 3) Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4) 75 years old or more than 75 years old 5) Life expectancy of at least 3 months after registration 6) Positive HER2 status(IHC3+ or IHC2+/FISH+) 7) Adequate organ function 8) Patient who is possible of ingestion 9) LVEF more than 50% 10) Normal electrocardiogram which was performed within 21 days 11) Written informed conscent
Exclusion criteria
Exclusion criteria: 1) Forbidden case to use S-1 and Trastuzumab 2) Infection or inflammatory case 3) Cardiovascular disease (congestive heart failure, Myocardial infarction, Ischemic heart disease, vulver disease) 4) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc. 5) Severe ascites and/or pleural effusion 6) Multiple bone metastasis 7) Clinical suspicion or previous history of metastasis to brain or meninges 8) Active digestive bleeding required repeat blood transfusion 9) severe diarrhea (4 times over /day) 10) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage 11) Complicated other active cancer 12) patient who want to be pregnant and /or pregnant woman 13) Intend to make pregnant 14) Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency and degree of adversed events | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, Overall response rate | — |
Countries
Japan
Contacts
Public ContactSachio Fushida
Kanazawa University Hospital Gastroenterological Surgery
Outcome results
None listed