colorectal cancer
Conditions
Interventions
TS-1 administered for 14 days followed by 7 days rest according to body surface area. L-OHP is administered intravenously in 100 mg/m2 at day 1. Bevacizumab is administered intravenously in 7.5 mg
Sponsors
University of Miyazaki Hospital.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Untreated recurrent or advanced colorectal cancer 2. Age 70=< 3. ECOG performance status of 0 to 2 4. The presence of evaluable disease based on the recist criterion. (within 30 days before registration) 5. No prior chemotherapy 6. Sufficient oral intake 7. Sufficient function of important organs Leu: >=4,000 /mm3, <=12,000 /mm3 Neu: >= 1,500 /mm3 Plt: >= 100,000 /mm3 Hemoglobin: >= 9.0 g/dL Total.bil: =< 2.0 mg/dL ALT<=100IU/L(ALT<=200IU/L with liver metastases) AST<=100IU/L(AST<=200IU/L with liver metastases) creatinine<=1.5mg/dL Ccr or eGFR: >= 50 ml/min proteinuria: =<2+ INR: =<1.5 8. Expected more than 3 months survival 9. With written informed consent
Exclusion criteria
Exclusion criteria: 1. History of the severe hypersensitivity 2. Active infection and inflammation 3. Patients have gastrointestinal perforation or bleeding 4. High grade peritoneal metastasis 5. Severe complications 6. Symptomatic or asymptomatic but treated heart disease 7. Patients have hemoptysis 8. Patients have peripheral sensory neuropathy 9. Watery stools or diarrhea 10. Massive pleural or abdominal effusion 11. Metastasis to CNS 12. History of the perforation of the digestive tract within 6 months before registration 13. History of the thromboembolism, brain infarction, lung infarction, brain infarction or pneumonitis 14. operation within 28 days 15. artificial anus within 14 days 16. congenital bleeding predisponency or abnormality of hemostasis 17. Patients have anticoagulant agent 18. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 19. Patients under treatment with flucytosine 20. With contraindicate TS-1, L-OHP, Bevacizumab 21. Patients under treatment with steroid 22. High-grade stricture 23. Pregnant or lactating woman or no birth-control 24. Other patients who are unfit for the study as determined by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival(OS), response rate(RR), and safety. | — |
Countries
Japan
Contacts
Public ContactKoji Nakashima
University of Miyazaki Hospital. First Department of Internal Medicine, Faculty of Medicine
Outcome results
None listed