Gastric cancer
Conditions
Interventions
cycle S-1:80-120mg/day. 2-4 cycle S-1:80-120mg/day. S-1 was given orally daily 2 weeks of 3week-cycle.Oxaliplatin 100mg/m2 was administered first cycle of 3 week-cycle as same schedule of S-1.
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological proven gastric cancer 2) Surgical operated by D2 lymphadenectomy and curability A 3) Clinical Stage IIIA,IIIB,IIIC(T2N3, T3N2-3, T4aN1-3, T4bN0-3) according to Japanese Classification of Gastric Cancer 14th edition 4) Age 20-80 years 5) No pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery 6) Capable of protocol therapy within 56 days after gastrectomy. 7) PS(ECOG) 0 or 1 8) Capable oral food uptake. 9) Clear to the criteria as below within 14days after registration. Hemoglobin:> 9.0 g/dL Leukocyte: >3,000 /mm3 <12,000 /mm3 Neutrophil: >1,500 /mm3 Blood platelet count: >100,000/mm3 Total bilirubin: <1.5mg/dl AST(GOT) ALT(GPT): <100 IU/L Creatinine clearance: >60 mL/min 10) Capable to have given written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) Active synchronous metachronous malignancy with longer than 5year interval period without below written cases Carcinoma in situ of cervical cancer and focal cancer in adenoma of colorectal cancer. 2) Contraindication of S-1 and Oxaliplatin 3) Regular use of flucytosine, phenytoin or warfarin potassium 4) Active infection with over 38 degree fever 5) History of serious drug hypersensitivity 6) Any other serious illness or medical conditions including interstitial paresis, intestinal obstruction, pneumonitis, pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure. 7) HIV positive or active hepatitis 8) Severe diarrhea (over 4 times/day or watery diarrhea) 9) Pregnancy or lactation 10) Male intension that get with child 11) Patients who are recognized as inadequate patients by doctor with responsibility in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate of up to protocol treatment 5 courses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events occurrence rate | — |
Countries
Japan
Contacts
Public ContactKinji Kamiya
Hamamatsu University Hospital 2nd department of surgery
Outcome results
None listed