Pre-operative chemotherapy with mFOLFOX6+Bevacizumab in liver only metastases from colorectal cancer -Phase II feasibility study-

UMIN ID: UMIN000001961

Registered date:01/06/2009

Basic Information

• Health condition(s) or Problem(s) studied: colorectal cancers
• Date of first enrollment: 2008/12/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Surgery

Outcome(s)

• Primary Outcome: Feasibility
• Secondary Outcome: R0(have tumor free margin) + R1(no tumor free margin)rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Active or previous history of interstitial pneumonia or pulmonary fibrosis confirmed by chest X-ray 2) Fluid retention requiring treatment 3) Other active malignancies unless the patient has been disease-free and received no treatment for the malignancy for &<5 years prior to study entry. 4) Peripheral neuropathy 5) Active infectious diseases 6) Ileus, Diarrhea 7) Diabetes mellitus, uncontrolled or controlled with chronic insulin therapy 8) Gastrointestinal perforation either concurrently or within 1 year prior to study entry 9) Previous history of ischemic heart disease 10,13) Psychiatric or medical condition that would preclude study compliance 11) Positive for HIV antibody and/or HBs antigen and/or HCV antibody 12) Concurrent chronic steroid therapy 14) Concurrent antithrombotic therapy 15) Chronic therapy with platelet function inhibitor 16) Evidence of bleeding diathesis or coagulopathy 17) Uncontrolled hypertension 18) Pregnant or lactating women, or fertile women of childbearing potential not using adequate contraception 19) Previous history of severe drug hypersensitivity 20) Any other conditions that would preclude study compliance

Related Information

• Primary Sponsor: Dept.Surgery Kanazawa University Hospital
• Source(s) of Monetary Support: Dept.Surgery Kanazawa University Hospital