advanced/recurrent gastric cancer
Conditions
Interventions
Treatment Methd CDDP 30mg/m2:day 1, day15, PTX 70mg/m2:day 1, day15, TS-1 80/mgm2:day1 &
21(on), day22 &
35(off) A 5 weeks is the one course
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) diagnosed histologicaly and/or cytologicaly (2) with measurable lesions (3) without any prior therapy except patients who have received other Chemotherapies than CDDP, PTX or TS-1 before 4 weeks of this Study (4) with normal organ functions 1) Hb <= 8.0g/dL 2) WBC:4,000-12000/mm3 3) Neutro: <=2000/mm3 4) Platelet: <=10x104/mm3 5) T.bil: >=1.5mg/dL 6) AST/ALT: <100 IU/L or <150 IU/L in patients with liver Metastasis 7) sCr <= 1.2mg/dL1. 8) CCr >= 60mL/min in Cockcroft-Gault method (5) PS 0-2 (6) longer than 3 months of the expected survival period (7) age between 20 and 75 years old (8) patients who can take orally (9) with written informed consent
Exclusion criteria
Exclusion criteria: (1) with bleeding from digestive tract (2) patients who cannot take orally due to some stenosis on digestive tract (3) past history of severe allergy against some medicines (4) with high volume of ascites and/or thoratic fluid (5) with severe diseases (infection, interstitial pneumonitis, pulmonary fibrosis, cardiac failure, renal failure, liver disease, uncontrollable DM) (6) with liver cirrhosis and/or jaundice (7) with psychologic disorder which needs medicines (8) with brain disorder due to brain metastasis (9) with active second cancers. (10) women under pregnancy or women expecting future birth (11) doctors decision not to register to this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival(OS),progression free survival, and Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactHiroshi Furukawa
Kinki University Faculty of Medicen Department of surgery
Outcome results
None listed