Unresectable advanced/recurrent colorectal cancer
Conditions
Interventions
1-6 Course Bevacizumab+mFOLFOX6 7-18 Course Bevacizumab+sLV5FU2 19- Course Bevacizumab+mFOLFOX6
Sponsors
The Tokyo Cooperative Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written IC 2. Age 20 to 74 3. Performance status 0-1(ECOG) 4. Life expectancy estimated>=3 months 5. Histologically confirmed Colorectal Cancer 6. With at least one measurable lesion 7. Sufficient organ functions
Exclusion criteria
Exclusion criteria: 1. Pleural effusion,peritoneal fluid,and pericardial fluid 2. Symptomatic brain metastasis 3. Active concomitant malignancy 4.With Neurological disorder of brain blood vessel 5. Any surgical treatmentsincluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks (except for a CV-port procedure one week or more earlier)or aspiration biopsy within one week 6. Administering antithrombotic drug to the thrombus syndrome within seven days 7. Anti-platelets therapy(including aspirin and NSAIDS) 8. Bleeding tendency,coagulation abnormality 9. Fresh hemorrhage from digestive tube,intestines tube paralysis,intestinal obstruction and uncontrolled peptic ulcer 10 current or previous (within one year) history of GI perforation 11. Traumatic fracture of unrecovery 12. Renal damage that requires treatment 13. High blood pressure and diabetic that cannot be controlled 14. Symptomatic or asymptomatic but treated heart disease 15. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium 16. Interstitial pneumonitis, pulmonary fibrosis 17. Peripheral neuropathy of grade 1(CTCAE v.3.0) or more 18. Infectious disease that cannot be controlled 19. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 20. Man who doesn't have intention to which it practices birth control 21. Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of disease control | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Reintroduction rate Overall response rate Overall survival | — |
Countries
Japan
Contacts
Public ContactTCOG Gastric Cancer affairs office
The Tokyo Cooperative Oncology Group Clinical Study Promotion Agency
Outcome results
None listed