Patients with unresectable or metastatic gastric cancer
Conditions
Interventions
................Day1........day15.......day21.......day35 CDDP....*...............* PTX........*...............* TS-1......80, 100, 120mg/day.......interval .................Day1 - day21........
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) gastric cancer proven histologically 2) with measurable lesion or detectable lesion 3) without prior chemotherapy (radiation therapy, chemotherapy or hormone therapy) Patients with the last prior therapy before more than 4 weeks of registration can be registered. 4) sufficient function of important organs from the deta before 2 weeks of registration O hemoglobin: >= 8.0 mg/dl O WBC: >= 4,000 and =< 12,000/mm3 O Platelet: >= 100,000/mm3 O sGOT,sGPT: < 100 IU/L O sT.bil.: <= 1.5 mg/dl O sCreatinin: <= upper limit of each institute *Creatinin clearance: >= 60 ml/min (Cockcroft-Gault method) 5) age: =>20 and 75=> 6) Performance Status: 0-1 (ECOG criteria) 7) more than 3 months of expected survival period 8) patients who can take food orally 9) written informed consent
Exclusion criteria
Exclusion criteria: 1) with fresh intestinal bleeding 2) patient who cannot be administered anticancer agents due to intestinal obstraction 3) history of severe allergy against drug 4) with severe thoracic fluid and/or ascites 5) with severe diseases (infection, interstitial pneumonitis, pulmonary fibrosis, cardiac failure, liver dysfunction, renal dysfunction or uncontrolled DM) which disturb registration to this study 6) with liver scirrhosis and/ or jaundice 7) patients with mental disprder who need medicines and/or treatments 8) with brain metastasis and its symptoms 9) with active double cancer 10) pregnant women or women who like to be pregnant 11) doctor's dicision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events, maximum tolerated dose, recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate(RECIST) | — |
Countries
Japan
Contacts
Public ContactFurukawa Hiroshi
Sakai City Hospital Director
Outcome results
None listed