UMIN ID: UMIN000001450
Registered date:21/10/2008
Phase II trial of neoadjuvant combination chemotherapy with gemcitabine and S-1 for locally advanced pancreatic cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | locally advanced pancreatic cancer |
| Date of first enrollment | 2008/12/01 |
| Target sample size | 35 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | S1: bid d1-15 q3w x 3 courses 60mg/sq PO GEM: d1 and d1, q3w x 3 courses 1000mg/sq DIV |
Outcome(s)
| Primary Outcome | pathologically margin negative status |
|---|---|
| Secondary Outcome | response rate, toxicity, progression free survival, overall survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)Watery diarrhea 2)Severe mental disorder 3)Active infection 4)Severe complications, such as ileus, heart failure and renal failure 5)Symptomatic pulmonary fibrosis or interstitial pneumonia 6)History of radiation therapy to the chest 7)Marked pleural or peritoneal effusion 8)Active concomitant malignancy 9)Treatment with phenytoin, potassium warfarin or flucytosine |
Related Information
| Primary Sponsor | Faculty of Medicine, Kyoto University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| tmasui@kuhp.kyoto-u.ac.jp | |
| Affiliation | Kyoto University Surgery |
| scientific contact | |
| Name | Yoshiya Kawaguchi |
| Address | 54 Kawaharacho, Shogoin, Sakyo, Kyoto Japan |
| Telephone | |
| Affiliation | Faculty of Medicine, Kyoto University Surgery |