advanced colorectal cancer
Conditions
Interventions
6 cycles of bi-weekly mFOLFOX6 plus bevacizumab regimen is followed by 6 cycles of bi-weekly sLV5FU2 plus bevacizumab regimen. Agter the 12 cycle treatment, 6 cycles of bi-weekly mFOLFOX6 plus bevaciz
Sponsors
Tohoku Clinical oncology, reserach and Education Society (T-CORE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. patient of pathologically defined colorectal cancer with RECIST-based mesurable disease. 2. No prior therapy including chemotherapy, immunotherapy and radiotherapy (including radiotherapy for pain control). Patient who previously recieved 5-FU-based adjuvant therpy other than FOLFOX iis eligible if it has been completed 6 months or more before registration. 3. age 20 years old or elder 4. predictive survival period is more than 12 weeks. 5. 4 weeks or more after surgery. 6. performance status (ECOG) is 0 or 1. 7. No obvious organ failures (bone marrow, heart, lung, liver, kidiney etc.) and satisfy the following laboratory data: (1) WBC: 3,000-12,000/mm3 (2) neutrophiles: 1,500/mm3 or more (3) platelets: 100,000/mm3 or more (4) totai bilirubin: 1.5 times of institutional upper limt or less (5) AST(GOT), ALT(GPT) and ALP: 2.5 times of institutional upper limt or less (in case with metastatic liver tumor, 5 times of institutional upper limt or less) (6)serum creatinin: institutional upper limt or less (7) creatinine clearance (Cockcroft-Gault method available): 50ml/min or more (8) written informed consent with patient signature and date
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. patient treated with blood transfusion, blood products or G-CSF within 7 days before registration. 2.patient who has or clinically suspicious for brain metastasis. 3. patient with a mental disorder or a history of a CNS disorder 4. patient with paresthesia 5. patient who need drainage of peritoneal, pleural or pericardial effusion. 6. double cancer 7. hypercalcemia (albumin-modified Ca value 12mg/dl or more). 8. poorly controlled diabetes mellitus. 9. proteinuria (grade 2 or more) 10. history of severe drug hypersensitivity or drug allergy 11. poorly controlled hypertension 12. obvious abnormality in ECG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median prpgression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate (RR), overall survival (OS), time to treatment failure (TTF), and incidence of neurotoxicity | — |
Countries
Japan
Contacts
Public ContactChikashi Ishioka
Tohoku Clinical oncology, reserach and Education Society (T-CORE) Administration Office
Outcome results
None listed