Colorectal cancer
Conditions
Interventions
Oxaliplatin 85 mg/m2, day1 S-1 80-120 mg/day, day 1-7 or alternate-day every 2 weeks
Sponsors
Epidemiological and Clinical research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histopathologically confirmed colorectal cancer 2) Previously received chemotherapy containing oxaliplatin and irinotecan 3) Not received oxaliplatin immediately before this trial 4) At least stable disease(SD) during previous oxaliplatin-based tratment 5) 6 months or over from the last introduction of oxaliplatin 6) Peripheral neuropathy<=grade1 7) Be able to take oral drugs 8) Mesurable lesion according to the RECIST 9) Age >= 20 years old 10) PS 0-2 11) A life expectancy of more than 12 weeks 12) No severe impairment of major organs (bone marrow,heart,lungs,liver,kidneys, etc) laboratory data within 14 days WBC >=2,000/mm3 and <= 12,000/mm3 Neutrophil >=1,000/mm3 Hemoglobin >=8.0 g/dL Platelet >=100,000/mm3 AST, ALT <=ULNx3.0 T-Bil <=ULNx1.5 Cr <=ULN Creatinine clearance >=40 mL/min 13) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Serious sensory abnormality or dysfunction 2) PD within 2 months during previous oxaliplatin-based therapy 3) Serious drug allergy 4) Presence of other active malignancies or a history of malignancies within the past 5 years 5) Blood transfusion or hemopoietic factors (G-CSF) within 7 days 6) Uncontrolled pleural effusion, ascites, or pericardial effusion 7) Clinically significant infection 8) Brain metastasis 9) Clinically significant heart disease (myocardial infarction within 12 months, etc) 10) Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure) 11) Fresh GI bleeding 12) Watery diarrhea 13) Central nervous system disorders 14) Dementia or clinically significant mental/neurological disorders 15) Patients who need flucytosine, phenytoin or warfarin potassium 16) Women who are pregnant, lactating, or wish to become pregnant 17) Investigator's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Time to treatment failure Response rate Dose intensity Relative dose intensity Adverse event | — |
Countries
Japan
Contacts
Public ContactYumi Miyashita
Epidemiological and Clinical research Information Network (ECRIN) Aichi branch
Outcome results
None listed