Colon cancer
Conditions
Interventions
Oxaliplatin 130 mg/m2 (day 1) S-1 80-120 mg/day (day1-14) to be repeated every 3 weeks.
Sponsors
Kyushu Study group of Clinical Cancer(KSCC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent 2) Patients who are judged to be suitable for receiving this protocol therapy by physician 3) Pathologically and Histologically confirmed colon adenocarcinoma 4) No prior chemotherapy and radiotherapy 5) Stage III, pathologically confirmed colon adenocarcinoma 6) R0 resection with D2 or D3 lymph node dissection was performed 7) Registration within 8 weeks after surgery 8) Age >= 20 years old 9) PS 0-1 10) Be able to take oral drugs 11) Recovery of postoperative complications 12) Required baseline laboratory parameters (within 14 days before registration): i) Neu >= 1,500/mm3 ii) Hb >= 9.0g/dL iii) Plt >= 100,000/mm3 iv) AST <= 100IU/L v) ALT <= 100IU/L vi) T-Bil < 2.0mg/dl vii) Ccr >= 60mL/min
Exclusion criteria
Exclusion criteria: 1) History of the severe hypersensitivity 2) Active other malignancies 3) Sensory neuropathy >= Grade 1 4) Diarrhea >= Grade 2 5) Active infections 6) History of mental disorder, central nerve disorder 7) Serious complication 8) Blood transfusion or hemopoietic factors (e.g. G-CSF) within 14 days 9) Pleural effusion, peritoneal fluid that needs treatment 10) Hemorrhagic diathesis, coagulation disorder 11) Patients who need flucytosine, phenytoin or warfarin potassium 12) Requiring steroid drug 13) Pregnant or lactating woman and man who hope for Partner's pregnant 14) Positive for HBs antigen and HCV antibody 15) Investigator's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-years Disease free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of completion of treatment as planned Adverse event Relative dose intensity Disease free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactKSCC
Clinical Research Support Center Kyushu KSCC
Outcome results
None listed