NIPH Clinical Trials Search

UMIN ID: UMIN000001568

Registered date:12/12/2008

Phase II trial of neoadjuvant chemotherapy with Bevacizumab plus FOLFOX6 chemotherapy for Resectable case of liver metastasis

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedsynchronous metastatic liver tumors of colorectal cancer
Date of first enrollment2008/06/01
Target sample size45
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Neoadjuvant chemotherapy with mFOLFOX6x1, mFOLFOX6+Bevacitumab x 6 and mFOLFOX6x1 followd by resection of origin


Primary Outcomeresponse rate
Secondary Outcomesafety, R-resection rate pathological response change of Grading disease free survival progression free survival overall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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.

Related Information


public contact
Name Kei Nakagawa
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN Japan
Telephone 022-717-7205
Affiliation Miyagi HBPCOG Division of Hepato-Biliary Pancreatic Surgery
scientific contact
Name Michiaki Unno
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN Japan
Telephone 022-717-7205
Affiliation Tohoku University Graduate School of Medicine Tohoku University Graduate School of Medicine, Division of Hepato-Biliary Pancreatic Surgery