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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015450
Receipt No. R000017963
Scientific Title Safety and efficacy of surgery following chemoradiation therapy in biliary tract cancer patients.
Date of disclosure of the study information 2014/11/01
Last modified on 2016/02/10

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Basic information
Public title Safety and efficacy of surgery following chemoradiation therapy in biliary tract cancer patients.
Acronym Surgery following chemoradiation in BTC patients.
Scientific Title Safety and efficacy of surgery following chemoradiation therapy in biliary tract cancer patients.
Scientific Title:Acronym Surgery following chemoradiation in BTC patients.
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of safety and efficacy of surgery following chemoradiation in biliary tract cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Efficacy of chemoradiation
(2) Safety of surgery following chemoradiation
(3) Efficacy of surgery following chemoradiation
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 chemoradiation and surgery
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. PS 0-1
2.1 Neutrophil>= 1,000 /mm3
2.2 Platelet>= 70,000 /mm3
2.3 Hb>= 8.0 g/dL
2.4 AST and ALT=< 400 U/L
2.5 Bilirubin=< 3.0 mg/dL*
2.6 creatinin=< 1.5 mg/dL
2.7 clinically normal ECG for surgery
3. written informed consent
Key exclusion criteria (1) possible R2 resection
(2) estimated residual liver volume < 35%, after portal embolization
(3) others
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shogo Kobayashi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Surgery
Zip code
Address Nakamichi 1-3-3, Higashinari-ku, Osaka city, Osaka 537-8511, Japan
TEL 06-6972-1181
Email s-kobayashi@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shogo Kobayashi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Surgery
Zip code
Address Nakamichi 1-3-3, Higashinari-ku, Osaka city, Osaka 537-8511, Japan
TEL 06-6972-1181
Homepage URL
Email s-kobayashi@umin.ac.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization
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 YES
Study ID_1 1408271143
Org. issuing International ID_1 Osaka Medical Center for Cancer and Cardiovascular Diseases
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪府立成人病センター

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Anticancer Res. 2016 Jan;36(1):335-42.
Cancer Chemother Pharmacol. 2015 Dec;76(6):1191-8. doi: 10.1007/s00280-015-2908-3. Epub 2015 Nov 7.

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 Main results already published
Date of protocol fixation
2014 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 16 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
2014 Year 10 Month 16 Day
Last modified on
2016 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017963

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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