Advanced gastric cancer
Conditions
Interventions
S-1 plus oxaliplatin (130 mg/m2, every 3 weeks)
Sponsors
Shizuoka Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed gastric adenocarcinoma 2) Unresectable advanced or recurrent gastric cancer 3) Adequate oral intake 4) Measurable or non-measurable disease 5) Age >= 20 years 6) Eastern Cooperative Oncology Group Performance status 0 or 1 7) HER-2 negative, or unknown at registration 8) No prior chemotherapy, immunotherapy or radiation therapy for advanced disease 9) Adequate organ function 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Massive ascites 2) Massive pleural effusion 3) Evidence of central nervous system metastasis, or clinically suspected 4) Poorly controlled diabetes mellitus 5) Serious lung or cardiovascular disease 6) Active concomitant malignancy 7) Active infection 8) Diarrhea 9) Peripheral neuropathy 10) Blood transfusion, blood products or G-CSF within 21 days at registration 11) Pregnant, nursing or unwilling to practice contraception during the study 12) Severe mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who recieved at least 80% of the planned dose for the first three cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, progression-free survival, overall survival, treatment discontinuation due to adverse events, and relative dose intensity | — |
Countries
Japan
Contacts
Public ContactYosuke Kito
Shizuoka Cancer Center Division of Gastrointestinal Oncology
Outcome results
None listed