advanced and/or recurrent gastric cancer
Conditions
Interventions
S-1 is orally administered for 3 weeks followed by 2 weeks rest according to body surface area (80mg/m2/day). CDDP is administered intravenously in each dosage of level(60mg/m2/day) at day 8. Trastu
Sponsors
HOG-GC (Hiroshima oncology group of gastric cancer)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathological proven adenocarcinoma of inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach 2) HER2-positive tumors 3) Age 20-75 years 4) ECOG performance status<=2 5) Measurable disease or non-measurable but assessable disease 6)No prior chemotherapy except for adjuvant chemotherapy with S-1 7)Sufficient oral intake 8)Adequate organ function 9) Ejection fraction more than 50% by ultrasound or MUGA 10) Expected more than 3 months survival 11) With written informed consent
Exclusion criteria
Exclusion criteria: 1) history of a previous drug allergy 2) pregnant or nursing patient or with intent to bear baby 3)R1 gastrectomy 4)need continuing use of flucytosine, phenytoin, warfarin potassium 5)Active infection or other inflammatory disease 6)with severe allergy to Trastuzumab, S-1 and cisplatin 7)History of cardiac disease 8)patients with serious concomitant diseas 9)with diarrhea 10)with ascites or pleural effusion 11)with multiple bone metastasis 12)peripheral sensory neuropathy 13)with brain metastasis 14)received operation within 28 days 15)simultaneous or metachronous double cancers 16)with clinically important mental disorder need to treat 17)cannot stopped steroids or immunosuppressing drug 18)Infection with hepatitis B 19)Inappropriate for the trial at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Overall survival, Safety, | — |
Countries
Japan
Contacts
Public ContactTanabe Kazuaki
Hiroshima University Gastroenterological Surgery
Outcome results
None listed