HER2 negative advanced gastric cancer
Conditions
Interventions
Capecitabine plus CDDP therapy 1)Intravenous injection of 80mg/m2 of CDDP on day1 2) Oral administration of 2000mg/m2/day of Capecitabine from day1 to day15 3)Maximum administration of CDDP is six
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed diagnosis of adnenocarcinoma of the stomach 2) IHC 0 or 1, or Fish negative tumor 3) No prior treatment 4) Measurable lesions 5) Taking food orally 6) Performance status 0-2 7) An expected survival of at least 2 months 8) No serious organ dysfunction: a leukocyte count >3000/ul, <12000/ul a neutorophil count>1500/ul, a platelet count >100,000/ul, serum concentration of asparate (AST) and alanine aminotransferase (ALT) <100U/l a serum bilirubin concentration <1.5mg/dl a serum creatinine concentration<1.5mg/dl 9) All patinets gave written informed consent
Exclusion criteria
Exclusion criteria: 1) Past history of treatments with Capecitabine and CDDP 2) Past history of drug hypersensitivity for 5-FU 3) Serious infectious disease, or uncotrollable diabetes mellitus 4) Interstitial pneumonia, or lung fibrosis 5) Multiple cancers 6) a patients with DPD deficiency 7)pregnancy, intention of pregnancy in female 8)familiy planning 9)ineligibility according to the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS OS PFS and OS according to histological type PFS and OS accoroding to tumor site Safety | — |
Countries
Japan
Contacts
Public ContactChikara Kunisaki
Yokohama City University Medical Center Gastroenterological Center
Outcome results
None listed