UMIN ID: UMIN000001025
Registered date:15/02/2008
Phase I study of preoperative Docetaxel, Cisplatin and S-1 for patients with advanced gastric cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Patients with unresectable gastric cancer due to limited invasion and/or metastasis. |
| Date of first enrollment | 2007/10/01 |
| Target sample size | 24 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Docetaxel day 1, 15 Cisplatin dat 1, 15 S-1 80mg/m2 day 1-14 every 28 days for 2 cycles followed by gastrectomy |
Outcome(s)
| Primary Outcome | Safety |
|---|---|
| Secondary Outcome | Adverse events Ratio of complete treatment Response rate of preoperative chemotherapy |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Active infection 2. Other severe complications 3. Active double cancer 4. CNS metastasis 5. Pericardiac fluid 6. Mortor paralysis or peripheral neural disturbance. 7. History of severe allergy against drug. 8. Severe peritoneal metastasis 9. Pregnant women or women who like to be pregnant. 10. Doctor' s dicision not to be registered to this study. |
Related Information
| Primary Sponsor | Dept. of Gastroenterologic Surgery, Kanazawa University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Sachio Fushida |
| Address | Takara-machi 13-1, Kanazawa Japan |
| Telephone | 076-265-2362 |
| Affiliation | Kanazawa University Hospital Gastroenterologic Surgery |
| scientific contact | |
| Name | Takashi Fujimura |
| Address | Takara-machi 13-1, Kanazawa Japan |
| Telephone | 076-265-2362 |
| Affiliation | Kanazawa University Hospital Gastroenterologic Surgery |