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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004051
Receipt No. 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

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Basic information
Public title Feasibility study of S-1 in resected biliary tract cancer
Acronym Feasibility of BTCS
Scientific Title Feasibility study of S-1 in resected biliary tract cancer
Scientific Title:Acronym Feasibility of BTCS
Region
Japan

Condition
Condition biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 determine the feasibility of adjuvant chemotherapy of S-1 in resected biliary tract cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes completion of adjuvant chemotherapy of S-1
Key secondary outcomes dose intensity,toxicity, relapse-free survival, overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Konishi
Organization National Cancer Center Hospital East
Division name Division of Upper Abdominal Surgery
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email mkonishi@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Nakachi
Organization Obihiro Kyokai Hospital
Division name Gastroenterology
Zip code
Address Obihiro
TEL 0155-22-6600
Homepage URL
Email knakachi-gi@umin.org

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 17 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004884

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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