UMIN ID: UMIN000001365
Registered date:10/09/2008
Phase I/II study of triweekly administration regimen of irinotecan and TS-1 in patients with advanced colorectal cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | advanced colorectal cancer |
| Date of first enrollment | 2004/12/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Treatment : TS-1+CPT-11 |
Outcome(s)
| Primary Outcome | 1) Phase I To determine the recommended dose 2) Phase II Response Rate |
|---|---|
| Secondary Outcome | Safety, Overall survival, Progression free survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1) Massive pleural effusion or massive ascites (2) Symptomatic brain metastases (3) Active diarrhea |
Related Information
| Primary Sponsor | Kyushu Medical Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kyushu Medical Oncology Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hitoshi Kusaba |
| Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan Japan |
| Telephone | 092-642-5232 |
| Affiliation | Kyushu University Hospital Division of Hematology and Oncology |
| scientific contact | |
| Name | Eishi Baba |
| Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan Japan |
| Telephone | 092-642-5232 |
| Affiliation | Kyushu University Hospital Division of Hematology and Oncology |