gastric cancer
Conditions
Interventions
S-1 80mg/m2, day 1-14 Cisplatin 20mg/m2, day 1, 8 1 week rest
S-1 80mg/m2, day 1-21 Cisplatin 60mg/m2, day 8 2 week rest
Sponsors
Tsukuba Cancer Clinical Trial Group
Tsukuba Cancer Clinical Trial Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed gastric cancer 2)Unresectable locally advanced and/or metastatic gastric cancer 3)Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) 4)No prior radiotherapy, chemotherapy or hormone therapy 5)ECOG Performance status 0-1 6)Age 20 to 75 7)No complication with peritoneal dissemination 8)Adequate function of major organs as defined below: WBC 3,000-12,000/ul Neutrophil count >1,500/ul Hb >8.0g/dl Platelet >100,000/ul Bilirubin <1.5 mg/dL AST and ALT <Upper limited normal*2 IU/L Creatinine <Upper limited normal(mg/dL) Creatinine clearanse >60ml/min 9)Voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1)Serious drug hypersensitivity or a history of drug allergy 2)Administered of flucytosine, phenytoin or warfarin potassium 3)Active infections 4)Serious complications (e.g., interstitial pneumonitis, pulmonary fibrosis, uncontrolled diabetes mellitus, renal failure or hepatic failure) 5)Uncontrolled watery diarrhea 6)Severe ascites or pleural effusion 7)Active double cancer 8)Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers 9)Men who are currently attempting to conceive children 10)Judged ineligible for participation in the study by the investigator for safety reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate, Progression free survival, Overall survival, Time to treatment failure | — |
Countries
Japan
Contacts
Public ContactToshikazu Moriwaki
University of Tsukuba Gastroenterology
Outcome results
None listed