UMIN ID: UMIN000002081
Registered date:01/07/2009
preoperative combined chemothrapy with docetaxel, cisplatin and S-1 in local advanced gastric cancer; multicentric phase II study
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | local advanced gastric cancer (excluding T3-4, bulky N2 & N3 and giant type3 & type 4) |
| Date of first enrollment | 2009/07/01 |
| Target sample size | 55 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 2 courses of DCS therapy followed by gastrectomy. docetaxel 35mg/m2/ D1, 8/ q4w cisplatin 35mg/m2/ D1, 8/ q4w S-1 80mg/m2/ D1-14/ q4w |
Outcome(s)
| Primary Outcome | pathological response |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) obvious infection 2) severe complication 3) active other malignancies 4) distant metastases 5) motor palalysis or peripheral neuropathy 6) drug hypersensitivity 7) mental disorder 8) possibility of pregnancy 9) judged as unsuitable by the doctor in charge |
Related Information
| Primary Sponsor | Society for the study of DCS therapy |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Sachio Fushida |
| Address | 13-1 Takara-machi, Kanazawa Japan |
| Telephone | 076-265-2362 |
| fushida@staff.kanazawa-u.ac.jp | |
| Affiliation | Kanazawa University Hospital Gastroenterological Surgery |
| scientific contact | |
| Name | Atsushi Nashimoto |
| Address | 2-15-3 Kawagishi-chou, Niigata Japan |
| Telephone | 025-266-5112 |
| nasimoto@niigata-cc.jp | |
| Affiliation | Society for the study of DCS therapy Surgery, Niigata Cancer Center Hospital |