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) studied | Colorectal Cancer |
| Date of first enrollment | 2008/11/01 |
| Target sample size | 65 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Patients receive modified FOLFOX6 with bevacizumab (Treatment will be continued to 24 cycles unless the disease progression, unacceptable toxicity, or consent withdrawal.). |
Outcome(s)
| Primary Outcome | Efficacy: Response rate |
|---|---|
| Secondary Outcome | Efficacy: 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 minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patient with contraindication to oxaliplatin, 5-FU, l-LV, or Bevacizumab. |
Related Information
| Primary Sponsor | Yakult Honsha Co.,Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Yakult Honsha Co.,Ltd. |
| Secondary ID(s) |
Contact
| 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 |
| hirohiko-maeda@yakult.co.jp | |
| 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 |