NIPH Clinical Trials Search

UMIN ID: UMIN000002354

Registered date:01/09/2009

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-

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadvanced colorectal cancer
Date of first enrollment2009/04/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)(mFOLFOX7+bevacizumab)x8cycle followed by (sLV5FU2+bevacizumab)x8cycle, followed by (mFOLFOX7+bevacizumab)x8cycle is treated until progression


Primary OutcomeProgression Free Survival
Secondary OutcomePFS2: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 minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1, 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


public contact
Name Chihiro Kosugi, Toru Tezuka
Address 3426-3 Anesaki, Ichihara City Japan
Telephone 0436-62-1211
Affiliation Teikyo University Chiba Medical Center Dept of Surgery
scientific contact
Name Keiji Koda
Address 3426-3 Anesaki, Ichihara City, 2990111 Japan Japan
Telephone 0436-62-1211
Affiliation Teikyo University Chiba Medical Center Dept of Surgery