HER2-positive unresectable advanced gastric cancer
Conditions
Interventions
Oral fluoropyrimidine (capecitabine or S-1), oxaliplatin and trastuzumab
Sponsors
Nagoya University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stage IV or recurrence 2. HER2 positive 3. ECOG PS 0-1 4. LVEF>=50% on echo cardiogram 5. Grade 1 or less for diarrhea, stomatitis, hand-foot syndrome, and sensory peripheral nerve neuropathy 6. Laboratory data 1) Neutrophil>=1,500/microl 2) Platelet>=7,500/microl 3) AST<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 4) ALT<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 5) Creatinine clearance>=30 mL/min
Exclusion criteria
Exclusion criteria: 1. HER2 negative 2. Uncontrolled diabetes 3. Uncontrolled hypertension 4. Unstable angina pectoris 5. Synchronous cancers 6. Systemic infection requiring treatment 7. Fever above 38 degree Celsius 8. A possibility of pregnancy or during pregnancy, or lactating women 9. Continuous systemic administration of steroids 10. Resistance to trastuzumab 11. Peripheral neuropathy Grade 2 or more 12. Oxaliplatin allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression-free survival, and response rate | — |
Countries
Japan
Contacts
Public ContactOsamu MAEDA
Nagoya University Hospital Department of Clinical Oncology and Chemotherapy
Outcome results
None listed