UMIN ID: UMIN000000992
Registered date:24/01/2008
Phase I trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for cholangiocarcinoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | cholangiocarcinoma |
| Date of first enrollment | 2009/02/01 |
| Target sample size | 12 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | chemoradiation EXRT: 45Gy, 1.8Gy x 25 fr Gemcitabine Level 1: 400mg/m2 Level 2: 600mg/m2 Level 3: 800mg/m2 Level 4: 1000mg/m2 |
Outcome(s)
| Primary Outcome | determine the MTD of gemcitabine |
|---|---|
| Secondary Outcome | ratio of complete treatment therapy evaluation operative complication |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. obvious infection 2. fever up (over 38 Celsius) 3. severe complication of heart and lung 4. active double cancer 5. synptom of brain metastases 6. pericardial fluid 7. Previous history of severe drug-induced allergy 8. Pregnant |
Related Information
| Primary Sponsor | Hepato-biliary pancreatic surgery, Tohoku University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Hepato-biliary pancreatic surgery, Tohoku University Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yu KATAYOSE |
| Address | Japan |
| Telephone | 022-717-7000 |
| Affiliation | Tohoku University Hospital Hepato-biliary pancreatic surgery, |
| scientific contact | |
| Name | Michiaki Unno |
| Address | 1-1 Seiryomachi, Aobaku, Sendai Japan |
| Telephone | |
| Affiliation | Tohoku University Hospital Hepato-biliary pancreatic surgery, |