NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001396

Registered date:26/09/2008

Randomized phase III study of FOLFOX plus bevacizumab versus FOLFIRI plus bevacizumab for metastatic colorectal cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedmetastatic colorectal cancer
Date of first enrollment2008/09/01
Target sample size400
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)FOLFOX plus bevacizumab FOLFIRI plus bevacizumab

Outcome(s)

Primary OutcomeProgression free survival
Secondary OutcomeOverall survival, Time to treatment failure, Response rate, R0 resection rate, Toxicity, Quality of life

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1.Histologically documented metastatic measurable adenocarcinoma of the colorectum with no prior chemotherapies for metastatic disease. 2.Age: >20, <75. 3.ECOG PS of 0 or 1. 4.Adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters. 5.Written informed consent.
Exclude criteria1.Brain metastasis with symptoms. 2.Massive asites, pleural effusion or pericardial effusion. 3.Double cancer with in five years prior to enroll in this study. 4.Serious non-healing wound. 5.Major surgical procedure within 28 days prior to enroll in this study. 6.Minor surgical procedure within 14 days prior to enroll in this study. 7.Other serious concomitant disease. 8.Regular use of corticosteroid. 9.Regular use of anticoagulation therapy. 10.Peripheral neuropathy > Grade 1 at baseline. 11.Active infectious disease. 12.History of serious hypersensitivity. 13.Hepatitis B surface antigen. 14.Mental disorder. 15.Pregnant or nursing.

Related Information

Contact

public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
E-mail datacenter@wjog.jp
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Kentaro Yamazaki
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 Japan Japan
Telephone 055-989-5222
E-mail
Affiliation Shizuoka Cancer Center Division of Gastrointestinal Oncology and Endoscopy