Unique ID issued by UMIN | UMIN000004051 |
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Receipt number | R000004884 |
Scientific Title | Feasibility study of S-1 in resected biliary tract cancer |
Date of disclosure of the study information | 2010/08/20 |
Last modified on | 2019/03/05 12:32:14 |
Feasibility study of S-1 in resected biliary tract cancer
Feasibility of BTCS
Feasibility study of S-1 in resected biliary tract cancer
Feasibility of BTCS
Japan |
biliary tract cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
determine the feasibility of adjuvant chemotherapy of S-1 in resected biliary tract cancer
Safety,Efficacy
Exploratory
Explanatory
Phase II
completion of adjuvant chemotherapy of S-1
dose intensity,toxicity, relapse-free survival, overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1
20 | years-old | <= |
79 | years-old | >= |
Male
1)Pathlogically confirmed adenocarcinoma
2)Carcinoma of intrahepatic, extrahepatic, gallbladder or ampulla of vater
3)Complete surgical resection(R0 or R1)
4)Within 10 weeks after surgery
5)No distant metastasis or ascites
6)Performance Status of 0 or 1
7)Preserved bone marrow and hepato-renal function
8)written informed consent
1)History of chemotherapy for biliary tract cancer
2)Recerrence of disease
3)Pleural effusion or ascites
4)Uncontorollable diarrehea
5)Active infection
6)Severe complication
30
1st name | |
Middle name | |
Last name | Masaru Konishi |
National Cancer Center Hospital East
Division of Upper Abdominal Surgery
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
04-7133-1111
mkonishi@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Kohei Nakachi |
Obihiro Kyokai Hospital
Gastroenterology
Obihiro
0155-22-6600
knakachi-gi@umin.org
National Cancer Center Hospital East
National Cancer Center Hospital
Japanese Governmental office
NO
癌研究会有明病院(東京都)
杏林大学医学部(東京都)
国立がん研究センター中央病院(東京都)
埼玉県立がんセンター(埼玉県)
東京女子医大(東京都)
国立がん研究センター東病院(千葉県)
2010 | Year | 08 | Month | 20 | Day |
Published
Completed
2010 | Year | 05 | Month | 17 | Day |
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 08 | Month | 17 | Day |
2019 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004884
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