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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015484
Receipt No. R000017995
Scientific Title Clinical Study of the photodynamic therapy for the periferal lung cancer
Date of disclosure of the study information 2014/10/21
Last modified on 2014/10/20

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Basic information
Public title Clinical Study of the photodynamic therapy for the periferal lung cancer
Acronym PDT for periferal lung cancer
Scientific Title Clinical Study of the photodynamic therapy for the periferal lung cancer
Scientific Title:Acronym PDT for periferal lung cancer
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Medicine in general Pneumology Adult
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 180 days of PDT
Key secondary outcomes

Base
Study type

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 therapy
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
Maximum diameter of solid part adenocarcinoma of more than 50% of the nodule diameter
Patients who have been determined to be inappropriate as a subject upon the doctor's discretion
Target sample size 8

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

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

Sponsor
Institute Nippon Medical School Hospital
Institute
Department

Funding Source
Organization NA
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 東京医科大学
国立がん研究センター
旭川医科大学病院呼吸器センター
日本原子力研究開発機構量子ビーム応用部門

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 21 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 Preinitiation
Date of protocol fixation
2014 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 21 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 20 Day
Last modified on
2014 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017995

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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