Safety and efficacy of preoperative chemotherapy with mFOLFOX6+Bevacizumab in patients with liver-only metastases (H2, H3) from colorectal cancer; histological assessment of liver damage from preoperative chemotherapy.

UMIN ID: UMIN000001308

Registered date:08/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with liver-only metastases from colorectal cancer
• Date of first enrollment: 2008/06/17
• Target sample size: 39
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): mFOLFOX6+Bevacizumab was administered for six cycles, but sixth cycle of therapy did not include Bevacizumab. Surgery was planned 2 weeks after the last dose of chemotherapy, resulting in a gap of 6-9 weeks between surgery and the last Bevacizumab dose.

Outcome(s)

• Primary Outcome: Liver resection rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Administering antithrobotic drug within 7 days 2. Serious drug hypersensitivity or a history of drug allergy 3. Peripheral neuropathy 4. Active concomitant malignancy 5. Active infections 6. Serious complications (renal failure or hepatic failure) 7. High blood pressure and diabetic and hypercalcemia that cannot be controlled 8. symptomatic or asymptomatic but treated heart disease 9. interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 10. histry of mental disturbances or cerebrovascular attack 11. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 12. Current or previous (within one year) history of GI perforation 13. Plerral effusion, peritoneal fluid and pericardial fluid 14. Symptomatic brain metastasis 15. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 16. under coutinuous steroid therapy 17. Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 18. CV-port procedure within one week 19. Anti-platelets therapy (including aspirin and NSAIDS) 20. Bleeding tendency, coagulation abnormality 21. history of organ transplantation 22. Traumatic gracture of unrecovery 23. Bevacizumab used previous chemotherapy 24. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 25. Other conditions not suitable for this study

Related Information

• Primary Sponsor: Kyushu Study group of Clinical Cancer
• Source(s) of Monetary Support: CReS kyushu