metastatic colorectal cancer
Conditions
Interventions
XELIRI plus bevacizumab therapy Bevacizumab 7.5mg/kg day1 Irinotecan 160mg/m2 day1 Capecitabin 1,600mg/m2/day day1-15
Sponsors
Kitasato university school of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histological confirmation of colorectal cancer 2.Metastatic colorectal cancer which has prior therapy of Oxliplatin-based chemotherapy 3.Age over 20 4.Group(ECOG) Performance Status (PS) 0-1 5.Adequate organ function 6. Written consent is taken
Exclusion criteria
Exclusion criteria: 1. Metastases to the CNS 2. Complication of cerebrovascular disease or symptoms within 1 years 3. Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week 4. Patient with untreated traumatic bone fracture 5. History of gastrointestinal perforation within 1 year 6. uncontrolled peptic ulcer 7. Diathesis of bleeding (history of hemoptysis,including cavitation and/or necrosis in lung metastasis confirmed by imaging),coagulopathy. 8. Administering antithrombotic drug within 10 days before enrollment 9. anti-platelets therapy 10. History of thrombosis or cerebrovascular disorder 12. Serious heart disease 11. Uncontrolled high blood pressure 12. Massive pleural effusion or ascites that required drainage 13.Multiple primary cancer which heals within five years 14. Patient who have peripheral nerve disorder 15.Interstitial pneumonitis 16. Uncontrolled diarrhea 17.Severe infection disease 18. The patient who has the past of the organ transplantation to need an immunosuppressive drug 19.Pregnant or lactating women or women of childbearing potential 20.History of severe allergy with Bevacizumab or Capecitabine 21. History of adverse events related to DPD loss 22. Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Countries
Japan
Contacts
Public ContactTakeo Sato
Kitasato University School of Medicine Research and Development Center for Medical Education, Depertment of Clinical Skills Education
Outcome results
None listed