Gastric cancer
Conditions
Interventions
S-1:80-120mg/body/day,PO,day1-14, Oxaliplatin:130 mg/m2, IV day1, every 21 days for 2 cycles followed by D2 surgery
Sponsors
Kyoto Katsura Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma 2) Clinical Stage III gastric cancer 3) Age above 20 years old 4) ECOG performance status of 0 or 1 5) No previous chemotherapy,radiation therapy or surgery for gastric cancer 6) Adequate organ function 1. WBC:>=3,000/mm3,<12,000/mm3 2. Neutrophil:>=1,500/mm3 3. Platelet:>=100,000/mm3 4. Hemoglobin:>=9.0g/dL 5. AST(GOT)/ALT(GPT):<=100 IU/L 6. Total bilirubin:<=2.0mg/dL 7. Serum creatinine:<=1.2mg 8. Creatinine clearance:>=60 mL/min 7) Possible oral intake 8) Written informed consent from patient
Exclusion criteria
Exclusion criteria: 1) With active double or multiple cancers 2) Severe complications 3) With active infection 4) Past history of severe hypersensitivity to drugs 5) Under treatment with flucytosine 6) Under treatment with warfarin 7) Pregnant women, or women with the possibility of the pregnancy, Men who want let to pregnancy 8) Patients judged inappropriate for the study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Completion rate of neoadjuvant chemotherapy Completion rate of adjuvant chemotherapy Pathological response rate Incidence of adverse events of neoadjuvant chemotherapy Incidence of postoperative complications R0 resection rate Progression-free survival Overall survival Completion rate of laparoscopic surgery | — |
Countries
Japan
Contacts
Public ContactSayuri Konishi
Kyoto Katsura Hospital Department of Surgery, Gastro-Intestinal Center
Outcome results
None listed