Multicenter Phase II study of modified FOLFOX7(combination chemotherapy of infusional 5-FU/l-Leucovorin and intermittent Oxaliplatin)with bevacizumab in the first-line therapy of colorectal cancer - CRAFT trial-

UMIN ID: UMIN000002354

Registered date:01/09/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced colorectal cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): (mFOLFOX7+bevacizumab)x8cycle followed by (sLV5FU2+bevacizumab)x8cycle, followed by (mFOLFOX7+bevacizumab)x8cycle is treated until progression

Outcome(s)

• Primary Outcome: Progression Free Survival
• Secondary Outcome: PFS2:PFS between PD in msLV5FU2+bevacizumab and PD after Oxaliplatin reintroduction Response rate Response rate2: response rate in Oxaliplatin reintroduction Time to treatment failure Safely

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1, Need to drain malignant coelomic fluid 2, Symptomatic brain metastasis 3, Multiple primary cancer within 5years 4, With suspected complication of arterial thromboembolism (ex:cerebrovascular disease)or experienced thrombosis within 1year/ twice of thrombosis 5, Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks. 6, Planning a surgery during the study. 7, Administering antithrombotic drug within 14 days. 8, Need to administrate or having anti-platelets therapy (including aspirin and NSAIDS) 9, Bleeding tendency(including hemoptysis) or coagulation disorder (INR>=1.5) 10, Uncontrolled complication of peptic ulcer. 11, Current or previous (within one year) history of GI perforation 12, Serious renal complications or having 2+ uric protein 13, Uncontrolled High blood pressure. 14, Symptomatic or symptomatic or asymptomatic but treated heart disease but treated heart disease 15, Serious drug hypersensitivity or a history of drug allergy (5FU, oxalipratin, Levofolinate calcium) 16, Experienced adverse drug reaction caused by fluoropyrimidines with suspected dihydropyrimidine dehydrogenase (DPD) deficiency 17, Uncontrolled diarrhea 18, Peripheral neuropathy(Grade 1=<) 19, Uncontrolled infection 20, Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 21, Previously treated with bevacizumab or oxaliplatin 22, Other conditions not suitable for this study

Related Information

• Primary Sponsor: Epidemiological and Clinical Research Information Network (ECRIN)
• Source(s) of Monetary Support: Epidemiological and Clinical Research Information Network (ECRIN)