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

Phase 2

• Conditions: synchronous metastatic liver tumors of colorectal cancer

• Registration Number: JPRN-UMIN000001568
• Lead Sponsor: Miyagi HBPCOG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-12
• Study Completion: 2013-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified