Unique ID issued by UMIN | UMIN000000992 |
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Receipt number | R000001187 |
Scientific Title | Phase I trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for cholangiocarcinoma |
Date of disclosure of the study information | 2008/01/24 |
Last modified on | 2013/01/23 09:11:23 |
Phase I trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for cholangiocarcinoma
Phase I trial neoadjuvant chemoradiation therapy with gemcitabine for cholangiocarcinoma
Phase I trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for cholangiocarcinoma
Phase I trial neoadjuvant chemoradiation therapy with gemcitabine for cholangiocarcinoma
Japan |
cholangiocarcinoma
Hepato-biliary-pancreatic surgery |
Malignancy
NO
Phase I trial of neoadjuvant chemoradiation with gemcitabine and surgical resection for cholangiocarcinoma patients
Safety
Exploratory
Explanatory
Phase I
determine the MTD of gemcitabine
ratio of complete treatment
therapy evaluation
operative complication
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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
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
12
1st name | |
Middle name | |
Last name | Michiaki Unno |
Tohoku University Hospital
Hepato-biliary pancreatic surgery,
1-1 Seiryomachi, Aobaku, Sendai
1st name | |
Middle name | |
Last name | Yu KATAYOSE |
Tohoku University Hospital
Hepato-biliary pancreatic surgery,
022-717-7000
Hepato-biliary pancreatic surgery,
Tohoku University Hospital
Hepato-biliary pancreatic surgery,
Tohoku University Hospital
Self funding
NO
2008 | Year | 01 | Month | 24 | Day |
Published
Conclusions. The recommend dose of gemcitabine in our NACRAC study was determined to be 600mg/m2. Neoadjuvant chemoradiation with conventional resection including major hepatectomy was feasible. (Hepatogastroenterology. 2011 Nov-Dec;58(112):1866-72. doi: 10.5754/hge10106.)
Completed
2007 | Year | 09 | Month | 02 | Day |
2009 | Year | 02 | Month | 01 | Day |
2009 | Year | 08 | Month | 01 | Day |
2008 | Year | 01 | Month | 23 | Day |
2013 | Year | 01 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001187
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