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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021378
Receipt No. R000024653
Scientific Title Photodynamic therapy using talaporfin sodium in the multidisciplinary therapy for cholangiocarcinoma -safety and efficacy-
Date of disclosure of the study information 2016/03/07
Last modified on 2016/03/07

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Basic information
Public title Photodynamic therapy using talaporfin sodium in the multidisciplinary therapy for cholangiocarcinoma -safety and efficacy-
Acronym The safety and efficacy of photodynamic therapy using talaporfin sodium for cholangiocarcinoma
Scientific Title Photodynamic therapy using talaporfin sodium in the multidisciplinary therapy for cholangiocarcinoma -safety and efficacy-
Scientific Title:Acronym The safety and efficacy of photodynamic therapy using talaporfin sodium for cholangiocarcinoma
Region
Japan

Condition
Condition Cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The investigation for the safty and efficacy of photodynamic therapy using talaporfin sodium for the cholangiocarcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 The photosensitizer talaporfin sodium is
injected intravenously at a dose of 40 mg/m2) 6 hours before PDT. Photoactivation with the diode laser system is performed at 664 nm with a light dose of 100 J/cm2.
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 -Cholangiocarcinima
-No metastasis
-Total bilirubin <5mg/dL
-Performance status of 0, 1 or 2
Key exclusion criteria -Hypersensitivity for talaporfin sodium
-Uncontrollable infection
-Severe psychiatric disorder
-Severe comorbidity
-Pregnancy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Itaru Naitoh
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL +81-52-853-8211
Email inaito@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Itaru Naitoh
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL +81-52-853-8211
Homepage URL
Email inaito@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Hospital
Institute
Department

Funding Source
Organization Nagoya City University Hospital
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 03 Month 07 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
2013 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 17 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
2016 Year 03 Month 07 Day
Last modified on
2016 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024653

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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