Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer
1. Histological diagnosis of colorectal cancer. 2） Age: 18 - 75 years. 3） No prior
chemotherapy 4） ECOG Performance Status 0 to 2 5) A life expectancy of at least 3 months
6) Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC
≧3,500/mm3 and Neutrophil ≧2,000/mm3. Hb ≧10.0 g/dl. Platelet count ≧100,000/mm3. AST and
ALT ≦2.5 times the upper limit of normal (excluding liver metastasis). T-Bil ≦1.5 mg/dl.
Creatinine ≦1.5 mg/ dl. 7).Patients must have the ability to understand and the
willingness to sign a written informed contact document.
1. Patients receiving blood transfusion, blood derivatives or granulocyte-colony
stimulating factor within 7days prior to entering the study.
2. Patients can not have oral intake
3. Patients receiving Flucytosine treatment
4. Patients with severe pleural effusion or ascites.
5. Patients who have brown brain metastasis
6. Patients with diarrhea 4 or more times per day
7. Patients with active gastrointestinal bleeding.
8. Patients with intestinal obstruction
9. Patients with active infection.
10. Patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary
fibrosis, pulmonary emphysema)
11. Patients with serious complications (such as intestinal paralysis, intestinal
obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes
mellitus, heart failure, renal failure, or hepatic failure).
12. Patients with significant cardiac disease.
13. Patients with active multiple cancer.
14. Patients with neuropathy ≥ grade 2
15. Patients who are pregnant, are of childbearing potential, or breast-feeding.
16. Patients with severe mental disorder.
17. Patients with a history of serious allergic reaction.
18. Judged to be ineligible for this protocol by the investigation.