unresectable or recurrent gastric cancer
Conditions
Interventions
S-1, CDDP and PTX combination chemotherapy is conducted. The S-1 is administered for 14 days followed by 14 days rest according to body surface area. CDDP and PTX is administered intravenously in each
Sponsors
School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)confirmed gastric cancer by endscopic biopsy 2)inoperable and recurrent gastric cancer 3)have measurable tumor region (preferable that patient have the target region which matched to RECIST guideline) 4)more than 10mm of longest diameter by spiral computed tomography or more than 20mm of longest diameter by computed tomography. 5) No prior chemotherapy. Only the case who has passed six months or more since chemotherapy ended assumes is acceptable. 6) No prior radiotherapy. The case who has received radiotherapy for non target region is acceptable. 7) age: >=20 and <75 8) Performance status 0 or 1 9) Expected to survive more than 3 months 10) sufficient function of important organs 1.WBC: >=4,000/mm3 and <=12,000/mm3 2.Neu: >=2000/mm3 3.Platelet: >=100,000/mm3 4.sT.bil: 1.5mg/dl 5.AST, ALT: 2.5 times of normal range in each institute 6.Haemoglobin: >=9.0g/dL 7.Serum creati: <=1.5mg/dL 8.Ccr: >=60 ml/min/body 11) possible to oral intake 12) written informed consent
Exclusion criteria
Exclusion criteria: 1) with heart disease needed to treat (ex. ischemic cardiac disease, arrhythmia) Left ventricular hypertrophy according to high blood pressure, slight left ventricle load, slight right bundle branch block are acceptable. 2) Cardiac infarction that developed within six months 3) Cirrhosis and hepatitis of briskness 4) Breathing difficulties that require oxygen administration by interstitial pneumonia and lungs fiber syndrome, etc. 5) Gut freshness hemorrhage that repeatedly requires transfusion 6) with clinically important mental disorder need to treat or treating with mind drug 7) with uncontrollable diabetes mellitus 8) with intestinal obstruction and sub-intestinal obstruction 9) infection with fever or doubt it 10) Double cancer of briskness 11) brain metastasis with symptom 12) Acute inflammatory disorder 13) Peripheral neuropathy 14) history of severe drug anaphylaxis 15) history of severe anaphylaxis to drug included Cremohor EL or Stiffening castor oil 16) pregnant woman, breast-feeding woman, and possibility of pregnancy 17) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [phase I] Estimate the maximum tolerated dose (MTD) and recommended dose (RD) of PTX and CDDP [phase II] Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| [phase II] Overall Survival, Progression Free Survival, Adverse events | — |
Countries
Japan
Outcome results
None listed