UMIN ID: C000000270
Registered date:01/09/2011
feasibility study on CPT-11/TS-1 sequential therapy for TS-1-resistant unresectable gastric cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | gastric cancer |
| Date of first enrollment | 2004/09/01 |
| Target sample size | 45 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TS-1 is administered after CPT-11 and the effect is evaluated. |
Outcome(s)
| Primary Outcome | anti-tumor effect |
|---|---|
| Secondary Outcome | overall survival and progression-free survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | infection diarrhea colon paralysis or obstruction interstitial pneumonia or pulmonary fibrosis massive ascites or pleural effusion jaundice hypersensitivity against CPT-11 or S-1 co-administration with 5-flucytosine pregnant or its possibility multiple cancers other severe complications a patient judged as an inadequate case by his doctor |
Related Information
| Primary Sponsor | 1st Department of Internal Medicine,Hirosaki University, School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Taiho Pharmaceutical Co. Ltd. Daiichi Pharmaceutical Co. Ltd |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 5 Zaifu-cho, Hirosaki, 036-8562, Aomori Japan |
| Telephone | |
| Affiliation | Hirosaki University, School of Medicine 1st Department of Internal Medicine |
| scientific contact | |
| Name | Soh Saitoh |
| Address | 2-1-1 Higashi-tsukurimichi, Aomori 030-8553 Japan |
| Telephone | |
| Affiliation | Aomori prefectural central hospital Division of medical oncology |