Gastric cancer
Conditions
Interventions
S-1:80-120mg/body/day,PO,day1-14,Oxaliplatin130 mg/m2, IV day1, every 21 days for 3 cycles followed by surgery (laparoscopic or open gastrectomy, D2 lymph node dissection).Adjuvant chemotherapy(S-1)
Sponsors
Wakayama Medical University, Second Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma 2) Clinical Stage III gastric cancer 3) Age between 20 and 80 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) Positive HBs antigen or positive HCV antibody 5) Continuous systemic steroid therapy 6) Severe diarrhea 7) Past history of severe hypersensitivity to drugs 8) Under treatment with flucytosine 9) Under treatment with warfarin 10) Pregnant women, or women with the possibility of the pregnancy, Men who want let to pregnancy 11) Patients judged inappropriate for the study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent completion of the protocol treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Relapse-Free Survival, Time to Treatment Failure, Percent completion of neoadjuvant chemotherapy, Percent completion of adjuvant chemotherapy, Response Rate, Pathological response rate, Incidence of adverse events on neoadjuvant chemotherapy, Incidence of a postoperative complication, The rate of R0 resection, Percent completion of the protocol treatment in patients with over 75 years of age | — |
Countries
Japan
Contacts
Public ContactMasaki Nakamura
Wakayama Medical University Second Department of Surgery
Outcome results
None listed