UMIN ID: UMIN000003961
Registered date:28/07/2010
XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | advanced and recurrent colorectal cancer |
| Date of first enrollment | 2010/07/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 1000mg/m2 of oral Xeloda twice daily on days 1 through 14 every 3 weeks. L-OHP 130mg/m2 is administered intravenous injection on day 1. (Bevacizumab 7.5mg/kg is administered intravenous injection on day 1.) |
Outcome(s)
| Primary Outcome | FOLFOX(+bevacizumab) from PFS |
|---|---|
| Secondary Outcome | safety,cycle number of XELOX,Quolity of life(FACT-C) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)severe renal failure 2)severe hypersensitivity to have a history fluorouracil,lebohorinatokarushiumu, platinum, bevacizumab 3)activity with multiple cancers(After which no more than five years of activity) 4)brain metastases(only when using bevacizumab) 5)FOLFOX(+bevacizumab)treatment for 3 or more months after 6)In addition, if deemed unsuitable to participate in this study is the responsible physician |
Related Information
| Primary Sponsor | Kochi Health Sciences Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Akihito Tsuji |
| Address | Japan |
| Telephone | |
| Affiliation | Kochi Health Sciences Center Department of Medical Oncology |
| scientific contact | |
| Name | Akihito Tsuji |
| Address | 2125-1 Ike, Kochi-city,Kochi,Japan Japan |
| Telephone | |
| Affiliation | Kochi Health Sciences Center Department of Medical Oncology |