UMIN ID: UMIN000001252
Registered date:15/07/2008
Randomized phase III study of CPT-11 versus Weekly Paclitaxel for unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum |
| Date of first enrollment | 2007/08/01 |
| Target sample size | 220 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | CPT-11 Paclitaxel |
Outcome(s)
| Primary Outcome | overall survival |
|---|---|
| Secondary Outcome | response rate, progression free survival, toxicity, rate of subsequent chemotherapy |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Serious medical condition such as infection, heart disease 2.Massive pleural effusion or ascites or pericardial effusion 3.Hypersensitivity or neuropathy 4.Interstitial pneumonia 5.CNS metastasis 6.Pregnancy or breast-feeding |
Related Information
| Primary Sponsor | West Japan Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | YAKULT HONSHA Co., LTD DAIICHI SANKYO CO., LTD |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinichiro Nakamura |
| Address | Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan |
| Telephone | 06-6633-7400 |
| datacenter@wjog.jp | |
| Affiliation | West Japan Oncology Group WJOG datacenter |
| scientific contact | |
| Name | Shuichi Hironaka |
| Address | 666-2 Nitonacho Chuo-ku Chiba-shi Chiba 260-8717, Japan Japan |
| Telephone | 043-264-5431 |
| Affiliation | Chiba Cancer Center Division of Gastrointestinal Oncology |