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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009212
Receipt No. R000010812
Scientific Title Feasibility of Docetaxel-cisplatin as 3rd or 4th line treatment for recurrent or unresectable biliary tract cacner.
Date of disclosure of the study information 2012/11/01
Last modified on 2012/10/29

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Basic information
Public title Feasibility of Docetaxel-cisplatin as 3rd or 4th line treatment for recurrent or unresectable biliary tract cacner.
Acronym Feasibility of Docetaxel-cisplatin as 3rd or 4th line treatment for recurrent or unresectable biliary tract cacner.
Scientific Title Feasibility of Docetaxel-cisplatin as 3rd or 4th line treatment for recurrent or unresectable biliary tract cacner.
Scientific Title:Acronym Feasibility of Docetaxel-cisplatin as 3rd or 4th line treatment for recurrent or unresectable biliary tract cacner.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of Docetaxel-cisplatin treatmet as 3rd or 4th line for recurrence and unresectable biliary tract cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to progression
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Biliary tract cacner patients who has already administered gemcitabine,S-1,and cisplatine or patients who couldn't adminster such drugs for side effects.
Interventions/Control_2 Biliary tract cancer patients who has already administered gemcitabine,S-1,and cisplatine or patients who couldn't adminster such drugs for side effects and reject the option of Docetaxel-cisplatin treatment.
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 Biliary tract cacner patients who has already administered gemcitabine,S-1,and cisplatine or patients who couldn't adminster such drugs for side effects.
Key exclusion criteria If patients reject.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryutaro Mori
Organization Yokohama city university graduated school of medicine
Division name Department of Gastroenterological Surgery
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama-shi, Kanagawa prefecture
TEL 045-787-2650
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ryutaro Mori
Organization Yokohama city university graduated school of medicine
Division name Department of Gastroenterological Surgery
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama-shi, Kanagawa prefecture
TEL 045-787-2650
Homepage URL
Email

Sponsor
Institute yokohama city university graduated school of medicine Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization yokohama city university graduated school of medicine department of gastroenterological surgery
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 30 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
2012 Year 10 Month 29 Day
Last modified on
2012 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010812

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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