UMIN ID: C000000037
Registered date:05/08/2005
A Multicenter Randomized Controlled Trial to Evaluate the Effect of Adjuvant Chemotherapy using Gemcitabine After Resection of Pancreatic Cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | resectable pancreatic cancer |
| Date of first enrollment | 2002/04/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | adjuvant systemic chemotherapy with gemcitabine 1000mg/m2 IV on days 1, 8, 15 every 28 days x 3 courses observation |
Outcome(s)
| Primary Outcome | survival time, recurrence rate |
|---|---|
| Secondary Outcome | adverse effect |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | interstitial pneumonia, pulmonary fibrosis intractable pleural effusion distant metastasis other active cancers apparent infection sever postoperative complications active peptic ulcer episode of myocardial infarction within three months mental disorders pregnacy or patient's hope to be pregnant |
Related Information
| Primary Sponsor | Study Group for Adjuvant Chemotherapy of Pancreatic Cancer |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tomoo Kosuge |
| Address | Japan |
| Telephone | 03-3542-2511 |
| Affiliation | Office of the Study Group for Adjuvant Chemotherapy of Pancreatic Cancer National Cancer Center Hospital, HBP Surgery Division |
| scientific contact | |
| Name | Tomoo Kosuge |
| Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo Japan |
| Telephone | 03-3542-2511 |
| Affiliation | National Cancer Center Hospital HBP Surgery Division |