Phase II study of TS-1 / oxaliplatin(G-SOX) plus bevacizumab treatment for elderly advanced colorectal cancer patients.(GIANTS study)
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000009014
- Lead Sponsor
- niversity of Miyazaki Hospital.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival(PFS)
- Secondary Outcome Measures
Name Time Method overall survival(OS), response rate(RR), and safety.