Unique ID issued by UMIN | UMIN000000820 |
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Receipt number | R000000983 |
Scientific Title | Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer |
Date of disclosure of the study information | 2007/09/10 |
Last modified on | 2018/09/18 14:33:12 |
Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer
Bile Duct Cancer Adjuvant Trial (BCAT)
Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer
Bile Duct Cancer Adjuvant Trial (BCAT)
Japan |
Bile duct cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
The objective of the present study is to evaluate efficacy of adjuvant chemotherapy using gemcitabine in patients underwent R0/R1 resection for bile duct cancer.
Safety
Over All Survival Time
Adverse Events, Recurrence Free Survival Time
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Medicine |
Adjuvant chemoterapy with gemcitabine
Observation following surgery
20 | years-old | <= |
100 | years-old | >= |
Male and Female
1. Adenocarcinoma; Extrahepatic bile duct carcinoma or hilar type intrahepatic cholangiocarcinoma 2. UICC stage I or II or III, R0 or R1 3. ECOG PS 0 or 1 4. No chemotherapy or radiotherapy in the past 5 years 5. 3000/mm3<=WBC<=12000/mm3, Plt>=100000/mm3, Hb=>8.0 g/dL, T.Bil<=2.0mg/dL, AST<=100IU/L, ALT<=100IU/L, Cre<=1.5mg/dL
1. Pleural effusion or ascites, moderate amount 2. Pericardial effusion 3. NYHA class III or IV 4. Myocardiac infarction in the past 3 months 5. Active viral hepatitis 6. Uncontrolled Diabetes Melitus 7. Blood trasfusion in the past 2 weeks
300
1st name | |
Middle name | |
Last name | Masato Nagino |
Nagoya University, Graduate School of Medicine
Divison of Surgical Oncology
65 Tsurumaicho, Showaku, Nagoya, 466-8550, Japan
052-744-2223
1st name | |
Middle name | |
Last name | Tomoki Ebata |
Nagoya University, Graduate School of Medicine
Divison of Surgical Oncology
tomoki@med.nagoya-u.ac.jp
Nagoya Surgery Support Organization
Nagoya Surgery Support Organization
Non profit foundation
NO
2007 | Year | 09 | Month | 10 | Day |
Published
Completed
2007 | Year | 07 | Month | 20 | Day |
2007 | Year | 09 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2007 | Year | 09 | Month | 06 | Day |
2018 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000983
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