UMIN ID: UMIN000000549
Registered date:15/12/2006
A phase II study to evaluate the effect of adjuvant chemotherapy using hepatic arterial infusion chemotherapy of 5-fluorouracil plus systemic chemotherapy of 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 | 2006/12/01 |
| Target sample size | 25 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | adjuvant chemotherapy using hepatic arterial 5FU (1000mg/m2) plus systemic gemcitabine (1000mg/m2) on days 1, 8, 15 every 28 days x 6 courses |
Outcome(s)
| Primary Outcome | disease-free survival time |
|---|---|
| Secondary Outcome | adverse effect, treatment compliance, survival time |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) interstitial pneumonia, pulmonary fibrosis 2) intractable pleural effusion 3) intractable diabetes mellitus or liver dysfunction 4) distant metastasis 5) other active cancers 6) apparent infection 7) sever postoperative complications 8) active peptic ulcer 9) episode of myocardial infarction within three months 10) mental disorders 11) pregnacy or patient's hope to be pregnant |
Related Information
| Primary Sponsor | Nara Medical University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Nara Medical University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | Nara Medical University Department of Surgery |
| scientific contact | |
| Name | Masayuki Sho |
| Address | 840 Shijo-cho, Kashihara, Nara Japan |
| Telephone | 0744-29-8863 |
| Affiliation | Nara Medical University Department of Surgery |