gastric cancer
Conditions
Interventions
Intravenous infusion of trastuzumab (loading dose 8 mg/kg, 6 mg/kg) on day1, Intravenous administration of 40 mg/m2 docetaxel on Day 1, and oral administration of 80 mg/m2/day S-1 on Days 1 to 14 eve
Sponsors
Okayama University
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 20-79 years 4) Measurable disease or non-measurable but assessable disease 5) No prior chemotherapy except for adjuvant chemotherapy with S-1 6) Adequate organ function 7) ECOG performance status<=2 8) Ejection fraction more than 50% by ultrasound or MUGA 9) Expected more than 3 months survival 10) Sufficient oral intake 11) With written informed consent
Exclusion criteria
Exclusion criteria: 1) with severe allergy to Trastuzumab, S-1 and docetaxel 2) Active infection or other inflammatory disease 3) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 4) Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, uncontrollable diabetes millutus, hypertension, and respiratory insufficiency. 5) History of cardiac disease 6) Dyspnea at rest, due to complications of advanced malignancy or other cardiovascular disease 7) Metastasis to CNS 8) Grade 3-4 peripheral sensory neuropathy 9) pregnant or nursing patient or with intent to bear baby 10) Inappropriate for the trial at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, objective response rate, overall survival, time to treatment failure | — |
Countries
Japan
Contacts
Public ContactShunsuke Kagawa
Okayama University Hospital Department of Gastroenterological Surgery
Outcome results
None listed