UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021378 |
|---|---|
| Receipt number | 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 16:13:28 |
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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
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
inaito@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024653
