Gastric Cancer
Conditions
Interventions
1st course: TS-1 80mg/m2 Day1-14 q3w 2nd-8th course: Oxaliplatin 100mg/m2 Day1 TS-1 80mg/m2 Day1-14 q3w 9th course until end: TS-1 80mg/m2 Day1-28 q6w
Sponsors
Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed common type of gastric cancer with Stage IIIA, IIIB and IIIC 2. Completely resected gastric cancer with D2 lymphadenectomy 3. Without distant metastasis including positive peritoneal cytology 4. ECOG performance status are 0 or 1. 5. Within 6 weeks after surgical treatment 6. Without preoperative therapy (including chemotherapy or radiotherapy) 7. With adequate major organ functions within 14 days before trial entry, as defined below: 1) White blood cell count >= 4,000/mm3 or <=12,000mm3 2) Neutrophil count >= 1,500/mm3 3) Hemoglobin >= 9.0 g/dL 4) Platelet count >= 100,000/mm3 5) AST <= 100IU/L 6) ALT <= 100IU/L 7) Total Bilirubin<= 1.5 mg/dL 8) Serum Creatinine <= 1.2 mg/dL 9) Creatinine clearance >= 50ml/hr 10. Written informed consent must be taken by patients
Exclusion criteria
Exclusion criteria: 1. With synchronous or metachronous (within 5 year before entry) double cancer, except for situ carcinoma 2. Severe surgical complication 3. Severe complication; such as uncontrollable diabetes mellitus or hypertension 4.With Peripheral sensory neuropathy 5. Active infectious disease 6. Positive for HBs antigen or HCV antibody 7. Continuous administration of steroids 8. Severe diarrhea 9. With drug allergy for both of iodine and gadolinium 10. Continuous flucytosine, phenytoin, and warfarin potassium treatment 11. Women during pregnancy, possible pregnancy, or breast-feeding and men with making pregnant 12. Cases judged to be inappropriate by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of the patients who completed the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year Relapse-free survival 3 year overall survival Rate of adverse event Rate of peripheral sensory neuropathy | — |
Countries
Japan
Contacts
Public ContactHiroaki Tanaka
Osaka City University Graduate School of Medicine Departiment of Surgical Oncology
Outcome results
None listed