UMIN ID: C000000173
Registered date:01/10/2005
A phase II study of gemcitabine and S-1 combination therapy for metastatic pancreatic cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Metastatic pancreatic cancer |
| Date of first enrollment | 2004/10/01 |
| Target sample size | 55 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Gemcitabine+S-1 |
Outcome(s)
| Primary Outcome | Response rate |
|---|---|
| Secondary Outcome | Adverse event Progression free survival Survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 74years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)Pulmonary fibrosis or interstitial pneumonia, 2)Watery diarrhea, 3)Active infection (except for chronic viral hepatitis), 4)Severe complications, such as heart disease, renal failure, hepatic failure, and active gastric ulcer, 5)Marked pleural effusion or ascites, 6)Metastasis to the central nervous system, 7)Active concomitant malignancy, 8)Severe mental disorder, 9) Pregnancy or lactation |
Related Information
| Primary Sponsor | National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labor and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hideki Ueno, MD, PhD |
| Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan Japan |
| Telephone | 03-3542-2511 |
| hiueno@ncc.go.jp | |
| Affiliation | GS Therapy Coordination Office National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division |
| scientific contact | |
| Name | Takuji Okusaka, MD, PhD |
| Address | 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045, Japan Japan |
| Telephone | 03-3542-2511 |
| Affiliation | National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division |