colorectal cancers
Conditions
Interventions
Surgery
Sponsors
Dept.Surgery Kanazawa University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1,2) Histologically or cytologically confirmed colorectal cancer confined to the liver 3) No extrahepatic metastases (If present, primary tumor must be potentially resectable with curative intent) 4) Measurable disease 5) Resectable or unresectable disease 6) No prior chemotherapy or radiotherapy (Prior adjuvant chemotherapy for primary cancer is allowed provided it is other than FOLFOX and at least 24 weeks have passed since last treatment) 7) No prior locoregional therapy for liver metastases 8) Age 20 to 75 years old 9) ECOG performance status 0-1 10) Life expectancy of &>13 weeks at the time of enrollment 11) Adequate organ functions as follows: WBC 4,000-12,000/mm3 ANC>2,000/mm3 Platelet count>100,000 /mm3 Hemoglobin>9 g/dL AST or ALT< 3 times ULN Bilirubin<1.5 times ULN Creatinine<1.5 times ULN 12) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Active or previous history of interstitial pneumonia or pulmonary fibrosis confirmed by chest X-ray 2) Fluid retention requiring treatment 3) Other active malignancies unless the patient has been disease-free and received no treatment for the malignancy for &<5 years prior to study entry. 4) Peripheral neuropathy 5) Active infectious diseases 6) Ileus, Diarrhea 7) Diabetes mellitus, uncontrolled or controlled with chronic insulin therapy 8) Gastrointestinal perforation either concurrently or within 1 year prior to study entry 9) Previous history of ischemic heart disease 10,13) Psychiatric or medical condition that would preclude study compliance 11) Positive for HIV antibody and/or HBs antigen and/or HCV antibody 12) Concurrent chronic steroid therapy 14) Concurrent antithrombotic therapy 15) Chronic therapy with platelet function inhibitor 16) Evidence of bleeding diathesis or coagulopathy 17) Uncontrolled hypertension 18) Pregnant or lactating women, or fertile women of childbearing potential not using adequate contraception 19) Previous history of severe drug hypersensitivity 20) Any other conditions that would preclude study compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| R0(have tumor free margin) + R1(no tumor free margin)rate | — |
Countries
Japan
Contacts
Public ContactHideto Fujita
Kanazawa University Hospital Surgery
Outcome results
None listed