UMIN ID: UMIN000016446
Registered date:09/02/2015
XELODA Special Drug Use Surveillance, XELOX as adjuvant chemotherapy for colon cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | colon cancer |
| Date of first enrollment | 2015/02/09 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | ADR incidence according to creatinine clearance rate before XELOX |
|---|---|
| Secondary Outcome | Early, 4 cycles, withdrawal of XELOX according to creatinine clearance rate before XELOX |
Key inclusion & exclusion criteria
| Age minimum | 65years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients <65 years old when starting XELOX therapy 2) Patients without serum creatinine data before XELOX therapy 3) Patients who did not start XELOX therapy at the specified initial dose 4) Patients with other cancers |
Related Information
| Primary Sponsor | Chugai Pharmaceutical Co. Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Chugai Pharmaceutical Co. Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Makoto Nomura |
| Address | 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan Japan |
| Telephone | 03-3273-0773 |
| nomuramkt@chugai-pharm.co.jp | |
| Affiliation | Chugai Pharmaceutical Co. Ltd. Pharmacovigilance Dept. |
| scientific contact | |
| Name | Joji Mochizuki |
| Address | 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan Japan |
| Telephone | 03-3273-0773 |
| mochizukijuj@chugai-pharm.co.jp | |
| Affiliation | Chugai Pharmaceutical Co. Ltd. Pharmacovigilance Dept. |