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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021501
Receipt No. R000024797
Scientific Title Clinical study of photodynamic therapy for peripheral typelung cancers
Date of disclosure of the study information 2016/03/16
Last modified on 2018/03/18

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Basic information
Public title Clinical study of photodynamic therapy for peripheral typelung cancers
Acronym Clinical study of photodynamic therapy for peripheral typelung cancers
Scientific Title Clinical study of photodynamic therapy for peripheral typelung cancers
Scientific Title:Acronym Clinical study of photodynamic therapy for peripheral typelung cancers
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study the safety and efficacy of Photodynamic therapy for periferal lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of adverse event of grade 2 or more within 90 days of PDT
Key secondary outcomes Recurrence free survival rate at 90days and 1 year after PDT

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
Device,equipment Maneuver
Interventions/Control_1 Photodynamic theapy
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 Cancer nodule within 20mm in maximum measured by thin-slice CT
Negative for lymphnode or distant metastasis measured by FDG-PET, abdomnal CT or US, Brain CT or MRI.
ECOG PS 0-2
Over 20 years old
Platete: 100000~400000
PT-INR: less than 1.4
Diagnosed as non-small cell lung cancer by trans-bronchal biopsy or cytology
Inoperable case or Reject operation cases
with written informed concent
Key exclusion criteria Patients with anti-coagulant dose, except for salicylic acid formulation in the past week
women who are/may pregnant, or lactating
Patients with serious complications such as heart disease, liver disease and kidney failure
Patients who have the porphyria
Patients who have the sunlight hypersensitivity
Patients who have been determined to be inappropriate as a subject upon the doctor's discretion
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jitsuo Usuda
Organization Nippon Medical School Hospital
Division name Thoracic Surgery
Zip code
Address 1 Chome-1-5 Sendagi Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email jusuda@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jitsuo Usuda
Organization Nippon Medical School Hospital
Division name Thoracic Surgery
Zip code
Address 1 Chome-1-5 Sendagi Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email jusuda@nms.ac.jp

Sponsor
Institute Nippon Medical School Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
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

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 16 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 Completed
Date of protocol fixation
2016 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 16 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded
2018 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 16 Day
Last modified on
2018 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024797

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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