UMIN ID: UMIN000001754
Registered date:04/03/2009
Phase II trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patients
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | cholangiocarecinoma:Stage III and IV of the Japanese General Rules for Surgical and Pathological Studies on Cancer of the Biliary Tract |
| Date of first enrollment | 2008/12/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | chemoradiation EXRT: 45Gy, 1.8Gy x 25 fr Gemcitabine : 600mg/m2 |
Outcome(s)
| Primary Outcome | pathological curability |
|---|---|
| Secondary Outcome | safety, disease free survival, over all survival, pathological response |
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 9. Disqualified by attendig doctor |
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 | Kei Nakagawa |
| Address | 1-1 Seiryomachi, Aobaku, Sendai Japan |
| Telephone | 022-717-7205 |
| kein_h11@surg1.med.tohoku.ac.jp | |
| Affiliation | Tohoku University Hospital Hepato-biliary pancreatic surgery, |
| scientific contact | |
| Name | Michiaki Unno |
| Address | 1-1 Seiryomachi, Aobaku, Sendai Japan |
| Telephone | 022-717-7205 |
| m_unno@surg1.med.tohoku.ac.jp | |
| Affiliation | Tohoku University Hospital Hepato-biliary pancreatic surgery, |