UMIN ID: UMIN000000636
Registered date:30/08/2008
The efficacy and feasibility of the repeated intraperitoneal Paclitaxel +systemic TS-1 and Paclitaxel for far advanced or recurrent gastric cancer: Phase I/II trial.
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Far advanced or recurrent gastric cancer |
| Date of first enrollment | 2006/08/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 1.Oral TS-1 80mg/m2 every day 2.Intravenous Paclitaxel 50mg/m2 every week 3.intraperitoneal Paclitaxel every week 2 week administration and 1 week off x3 cycles |
Outcome(s)
| Primary Outcome | side effects 1-year survival |
|---|---|
| Secondary Outcome | plasma level of taxol response rate Duration of overall Response Duration of complete Response Duration of Stable DiseaseTime To Progression |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Other hematogeneous metastasis multiple cancers other cases who are decided to be inappropriate for the clinical trial by doctors. |
Related Information
| Primary Sponsor | Department of Surgical Oncology The University of Tokyo |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Grants-in-Aid for Scientific Research Japan society of the promotion of science |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Joji Kitayama |
| Address | Hongo 7-3-1, Bunkyo-ku, Tokyo Japan |
| Telephone | 03-3815-5411 |
| kitayama-1SU@h-u-tokyo.ac.jp | |
| Affiliation | The University of Tokyo Department of Surgical Oncology |
| scientific contact | |
| Name | Joji Kitayama |
| Address | Hongo 7-3-1, Bunkyo-ku, Tokyo Japan |
| Telephone | 03-3815-5411.33246 |
| Affiliation | The University of Tokyo Department of Surgical Oncology |