advanced/recurrent gastric cancer
Conditions
Interventions
Group A: TS-1(80mg/m2/day, between day 1 and 21) + CPT-11(80mg/m2/day, on day and day 15 ) are administered in every 5 weeks (1 course).
Group B: TS-1(80mg/m2/day between day 1 and 14) + Taxol(50mg/m2
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed gastric cancer, histologically 2)with metastatic lesions which can be measured 3) without any prior radiation therapy or chemotherapy using CPT-11, TXL or TS-1 4) Performance Status 0 or 2 in ECOG classification 5) age 20<= and =>75 6) sufficient oral intake 7) Survival period is expected over three months. 8) without any severe disorders in any organs 1. bone marrow function . WBC: 4,000/mm3<= and > 12,000/mm3 . Neutrocyte: 2,000 /mm3<= . Hb: 8.0 g/dl <= . Platelet: 100,000/mm3<= 2. Liver function . Total Bil.: 1.5 mg>= . GOT, GPT: < 100 IU/l 3 Renal Function . Creatinin: 1.2 mg/dl>= . Creatinin Clearance: 50 mg/mm <= (by Cockcroft-Gault) 9) Written Informed Consents
Exclusion criteria
Exclusion criteria: 1) active double cancer 2) with other severe diseases (ileus, interstitial pneumonia/pulmonary fibrosis, cardiac failure, renal dysfunction, liver dysfunction) 3) with infectious diseases 4) under condition of diarrhea 5) with marked chest or abdominal fluid 6) history of allergy against medicine 7) receiving fluoropyrimidine, antifungal flusitosine or Atazanabil sulfate 8) with gastrointestinal bleeding which needs blood transfusion 9) with liver cirrhosis or jaundice 10) with psychiatric disease which needs medicine 11) with cardiac disease which needs therapy 12) with uncontrolled D M 13) with metastasis to the central nerve system 14) under pregnancy or nursing the baby 15) excluded by doctor due to the other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate(RECIS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Progression free survival (PFS) 2.Overall survival (OS) 3.Adverse Events | — |
Countries
Japan
Contacts
Public ContactFujitani Kazumasa
National Hospital Orgamnzation Dpt.Surgery
Outcome results
None listed