colorectal cancer
Conditions
Interventions
FOLFOX4+Bevacizumab 5FU bolus: 400 mg/m2 d1,2 5FU infusion: 600 mg/m2/22h d1,2 Oxaliplatin: 85mg/m2 d1 l-LV: 100mg/m2 d1,2 bevacizumab: 5mg/kg d1 Bevacizumab 5mg/m2 d1 Q2w
Sponsors
Japanese foundation for cancer research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age 20-74 years old. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 4. Life expectancy greater than or equal to 3 months 5. Histological confirmation of colorectal cancer. 6. Previously untreated advanced colon or rectal (Rs-Ra) cancer. 7. Vital organ functions (listed below) are preserved within 2 weeks prior to entry. i. Neurtophils =or>1500/mm3 ii. Platelets =or<100,000/mm3 iii. Hemoglobin=or>9.0g/dl iv. AST and ALT =or<upper limit of normal (ULN)x2.5 (=or<ULNx5 in case of liver metastasis) v. Total bilirubin =or<upper limit of normal (ULN)x1.5 vi. Serum creatinine =or<upper limit of normal (ULN)x1.5 8. Initially considered as unresectable advanced colorectal Cancer.
Exclusion criteria
Exclusion criteria: 1. Malignant coelomic fluid. 2. Radiological evidence of CNS metastases or brain cancer. 3. Multiple primary cancer within 5 years. 4. Complication of cerebrovascular disease or symptoms within 1 year. 5. Any surgical treatments including skin open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. 6. Planned surgery during chemotherapy. 7. Administering antithrombotic drug within 10 days. 8. Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS). 9. Evidence of bleeding diathesis or coagulopathy. 10. Active gastrointestinal ulcer 11. Current or previous (within the last 1 year) history of GI perforation 12. Non healing fracture 13. Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry 14. Uncontrolled Hypertension 15. Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction 16. History of the serious hypersensitivity for Fluorouracil, leucovorin calcium or platinum agents. 17. Dihydropyrimidine Dehydrogenase Deficiency. 18. Uncontrolled diarrhea. 19. Evidence of interstinal lung disease, or pulmonary fibrosis. 20. Evidence of peripheral neuropathy. 21. CV access system implanted within 7 days before chemotherapy. 22. History of organ transplantation 23. Uncontrolled Active infection. 24. Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of neoadjuvant chemotherapy. Possibility of curative surgery. | — |
Countries
Japan
Contacts
Public ContactMitsukuni Suenaga
The cancer institute hospital of JFCR Gastroenterology center
Outcome results
None listed