NIPH Clinical Trials Search

UMIN ID: UMIN000001490

Registered date:10/11/2008

Multicenter phase II study of modified FOLFOX6 and bevacizumab in chemonaive advanced or recurrent colorectal cancer.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedColorectal Cancer
Date of first enrollment2008/11/01
Target sample size65
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Patients receive modified FOLFOX6 with bevacizumab (Treatment will be continued to 24 cycles unless the disease progression, unacceptable toxicity, or consent withdrawal.).


Primary OutcomeEfficacy: Response rate
Secondary OutcomeEfficacy: Progression free survival:PFS,Time to treatment failure:TTF,Time to failure of strategy:TFS,Overall survival:OS,Safety: Adverse events, Duration of peri-pheral neuropathyBiomarker, such as genomic, proteomic, and metabolomic expression, profiling to discriminate the response to the treatment from patients' blood samples.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatient with contraindication to oxaliplatin, 5-FU, l-LV, or Bevacizumab.

Related Information


public contact
Name Hirohiko Maeda
Address 3F Ginza-Kobiki Bldg.,16-21,Ginza 7-chome,Chuo-ku,Tokyo,104-0061 Japan Japan
Telephone 03-5550-8962
Affiliation Yakult Honsha Co.,Ltd. Pharmaceutical Development Department, Post Marketing Development Section
scientific contact
Name Kei Muro
Address 1-1 Kanokoden, Chikusa-ku, 464-8681, Nagoya Japan
Telephone 052-762-6111
Affiliation Aichi Cancer Center Department of Clinical Oncology