Gastric cancer
Conditions
Interventions
Sponsors
Department of Gastroenterology, Nagoya University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Gastric adenocarcinoma. HER2 IHC- or IHC1+, or IHC2+/FISH- 2) Stage IV 3) ECOG PS 0-1 4) No previous chemothrapy or radiation therapy 5) Laboratory data 1.WBC>=3,000/mimcrol 2.Neutrophil>=1,500/microl 3.Hemoglobin>=8.0 g/dL 4.Platelet>=100,000/microl 5.Total bilirubin<=1.5 mg/dL 6.AST(GOT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 7.ALT(GPT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 8.Serum creatinine<=1.3 mg/dL 9.Creatinine clearance>=60 mL/min 10.Ejection fraction on echo cardiogram>=50%
Exclusion criteria
Exclusion criteria: 1) HER2 IHC 3+, or IHC 2 and FISH+ 2) Uncontrolled diabetes 3) Uncontrolled hypertension 4) Unstable angina pectoris, or a history of myocardial infarction within six months 5) Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema 6) Synchronous cancers 7) Systemic infection requiring treatment 8) Fever above 38 degree Celsius 9) A possibility of pregnancy or during pregnancy, or lactating women 10) Psychosis or psychotic symptoms 11) Continuous systemic administration of steroids (oral or intravenous)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Japan
Contacts
Public ContactOsamu Maeda
Nagoya University Hospital Department of Gastroenterology
Outcome results
None listed