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) studied | synchronous metastatic liver tumors of colorectal cancer |
| Date of first enrollment | 2008/06/01 |
| Target sample size | 45 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Neoadjuvant chemotherapy with mFOLFOX6x1, mFOLFOX6+Bevacitumab x 6 and mFOLFOX6x1 followd by resection of origin |
Outcome(s)
| Primary Outcome | response rate |
|---|---|
| Secondary Outcome | safety, R-resection rate pathological response change of Grading disease free survival progression free survival overall survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Miyagi HBPCOG |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Tohoku University Graduate School of Medicine, Division of Hepato-Biliary Pancreatic Surgery |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kei Nakagawa |
| Address | 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN Japan |
| Telephone | 022-717-7205 |
| kein_h11@surg1.med.tohoku.ac.jp | |
| 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 |
| m_unno@surg1.med.tohoku.ac.jp | |
| Affiliation | Tohoku University Graduate School of Medicine Tohoku University Graduate School of Medicine, Division of Hepato-Biliary Pancreatic Surgery |