cholangiocarcinoma
Conditions
Interventions
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
Sponsors
Hepato-biliary pancreatic surgery, Tohoku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed as cholangiocarcinoma 2. Performancestatus is 0 or 1 3. Age are from 20 years old to 75 yeas old 4. survival is expected over 2 months 5. Function of main organ are enough as below, Hb over 10 g/dl. WBC is over 4000/mm3. Neutrophil is over 2000/mm3. Platlet is over1x104mm3. AST and ALT are within 5 times of normal limit. Total bilirubin is within 3 times of normal limit. Creatinine is 1.5 times within normal limit. 6. sign the letter of consent by voluntary agreement
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| determine the MTD of gemcitabine | — |
Secondary
| Measure | Time frame |
|---|---|
| ratio of complete treatment therapy evaluation operative complication | — |
Countries
Japan
Contacts
Public ContactYu KATAYOSE
Tohoku University Hospital Hepato-biliary pancreatic surgery,
Outcome results
None listed