synchronous metastatic liver tumors of colorectal cancer
Conditions
Interventions
Neoadjuvant chemotherapy with mFOLFOX6x1, mFOLFOX6+Bevacitumab x 6 and mFOLFOX6x1 followd by resection of origin
Sponsors
Miyagi HBPCOG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. colorectal cancer diagnosed by histopathology 2. first treatment for measurable synchronous liver metastases. Curative cases by D2 or D3 resection. 3. Enrollment is within 6 weeks after original resection. 4. Written informed consent. 5. Age are from 20 to 74 years old. 6. PS by ECOG is 0 and 1. 7. a life expectancy greater than 3 months. 8. Function of main organ is kept as below, adequate hematologic function (leucocyte count > 3,000/uL, granulocyte count > 1,500/uL, hemoglobin level > 9.0 g/dL, and platelet count > 100,000/uL), adequate renal function (serum creatinine concentration < 1.5). Total bilirubin is within 1.5 times of normal limits. AST and ALT are within 5 times of normal limits. ALP is within 5 times of normal limits. Creatinin is within normal limits. (7) Written informed consent 9. Criteria of operable metastases are below, 1. Within 10 metastases, 2. Liver function is A by Child-Pough classification. 3. Operable case is judged by HBP surgeon.
Exclusion criteria
Exclusion criteria: 1. No extrahepatic lesion 2. No carcinomatous fluid 3. No brain tumor and brain metastases 4. Another cancer with disease free survival within 5 year 5. No cranial nerve and vessel problem, and no past history within 1 year of cranial nerve and vessel problem 6. Operation and incisional biopsy within 2 weeks. Or punctual cytology within 1 week. 7. Thrombosis with present and past history 8. Oral taking with Aspirin and steroid for RA and chronic inflammatory disease 9. Bleeding tendency and clotting abnormality 10. Uncontrollable peptic ulcer disease 11. Perforation of GI tract within 1 year 12. Untreatment of traumatic bone fracture 13. Require treatment of renal dysfunction, or urine protein > +2 within 2 weeks. 14. Uncontrollable hypertension 15. Cardiac disease (over Grade 2 by CTCAE v3.0). Or myocardial infarction within 1 year. 16. No severe anaphylaxis of Leucovorin(LV), 5-Fluorouracil(5-FU) and L-OHP 17. Uncontrollable diarrhea 18. interstitial lung disease, pulmonary fibrosis 19. organ recipient receiving an immunosuppressant 20. Uncontrollable infection 21. pregnant woman, lactating woman, positive of pregnancy test. Or no willing of birth-control 22. case whom principal investigator deny the enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, R-resection rate pathological response change of Grading disease free survival progression free survival overall survival | — |
Countries
Japan
Contacts
Public ContactKei Nakagawa
Miyagi HBPCOG Division of Hepato-Biliary Pancreatic Surgery
Outcome results
None listed