advanced colorectal cancer
Conditions
Interventions
(mFOLFOX7+bevacizumab)x8cycle followed by (sLV5FU2+bevacizumab)x8cycle, followed by (mFOLFOX7+bevacizumab)x8cycle is treated until progression
Sponsors
Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Written informed consents 2, Age: 20-79 years old 3, Performance Status(ECOG): 0-1 4, Life expectancy estimated>= 3 months 5, Histlogical confirmed colorectal cancer 6, With estimative lesion 7, Untreated for advanced or recurrence colorectal cancer (8) Sufficient organ functions 1 WBC=<4,000/mm3, Neurtophils >=2,000/mm3 2 Platelets>=100,000/mm3 3 Hemoglobin>=9.0g/dl 4 Total bilirubin=<upper limit of normal (ULN)x1.5 5 AST and ALT=<upper limit of normal (ULN)x2.5 (=<ULNx5 in case of liver metastasis) 6 Serum creatinine =<upper limit of normal (ULN)x1.5
Exclusion criteria
Exclusion criteria: 1, Need to drain malignant coelomic fluid 2, Symptomatic brain metastasis 3, Multiple primary cancer within 5years 4, With suspected complication of arterial thromboembolism (ex:cerebrovascular disease)or experienced thrombosis within 1year/ twice of thrombosis 5, Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks. 6, Planning a surgery during the study. 7, Administering antithrombotic drug within 14 days. 8, Need to administrate or having anti-platelets therapy (including aspirin and NSAIDS) 9, Bleeding tendency(including hemoptysis) or coagulation disorder (INR>=1.5) 10, Uncontrolled complication of peptic ulcer. 11, Current or previous (within one year) history of GI perforation 12, Serious renal complications or having 2+ uric protein 13, Uncontrolled High blood pressure. 14, Symptomatic or symptomatic or asymptomatic but treated heart disease but treated heart disease 15, Serious drug hypersensitivity or a history of drug allergy (5FU, oxalipratin, Levofolinate calcium) 16, Experienced adverse drug reaction caused by fluoropyrimidines with suspected dihydropyrimidine dehydrogenase (DPD) deficiency 17, Uncontrolled diarrhea 18, Peripheral neuropathy(Grade 1=<) 19, Uncontrolled infection 20, Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 21, Previously treated with bevacizumab or oxaliplatin 22, Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS2:PFS between PD in msLV5FU2+bevacizumab and PD after Oxaliplatin reintroduction Response rate Response rate2: response rate in Oxaliplatin reintroduction Time to treatment failure Safely | — |
Countries
Japan
Contacts
Public ContactChihiro Kosugi, Toru Tezuka
Teikyo University Chiba Medical Center Dept of Surgery
Outcome results
None listed