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) studied | metastatic colorectal cancer |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 400 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | FOLFOX plus bevacizumab FOLFIRI plus bevacizumab |
Outcome(s)
| Primary Outcome | Progression free survival |
|---|---|
| Secondary Outcome | Overall survival, Time to treatment failure, Response rate, R0 resection rate, Toxicity, Quality of life |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.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
| Primary Sponsor | West Japan Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
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 |
| 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 |
| Affiliation | Shizuoka Cancer Center Division of Gastrointestinal Oncology and Endoscopy |