resectable advanced gastric cancer
Conditions
Interventions
TS-1 administered for 14 days followed by 7 days rest according to body surface area. Cisplatin is administered intravenously in dosage of level at day 1 and day 8. Paclitaxel is administered intrav
Sponsors
Kinki University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histopathological confirmation of Adenocarcinoma 2) resectable advanced gastric cancer 3) measurable disease 4) Age over 20 5) ECOG performance status of 0 to 2 6) Sufficient function of important organs Leu : &#8805; 500 /mm3 and&#8804;12,000 /mm3 Neu : &#8805; 2,000 /mm3 Plate : &#8805; 100,000 /mm3 hemoglobin : &#8805; 9.0 g/dL AST, ALT : <100 IU/L St.bil : < 1.5 mg/dL Ccr : &#8805;60 ml/min 7) Ability to ingestion intake and drug administration orally. 8) Informed consent is obtained.
Exclusion criteria
Exclusion criteria: 1) With severe allergy to TS-1, Cisplatin and Paclitaxel 2) Women who are pregnant or breastfeeding. 3) Men who are unwilling to avoid pregnancy. 4) Active infection and inflammation. 5) History of cardiac disease 6) Dyspnea at rest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response rate recurrence-free survival time progression-free survival overall survival proportion of transit surgery proportion of R0 resection Accomplishment rate down stage rate frequency and grade of adverse postoperative complication frequency and grade of adverse event | — |
Countries
Japan
Contacts
Public ContactMotohiro Imano
Kinki University Faculty of Medicine Department of Surgery
Outcome results
None listed