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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004166
Receipt No. R000004654
Scientific Title A protocol of 3-D conformal external beam radiotherapy planning for lung cancer with functional lung
Date of disclosure of the study information 2010/10/01
Last modified on 2017/02/01

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Basic information
Public title A protocol of 3-D conformal external beam radiotherapy planning for lung cancer with functional lung
Acronym Functional lung protocol
Scientific Title A protocol of 3-D conformal external beam radiotherapy planning for lung cancer with functional lung
Scientific Title:Acronym Functional lung protocol
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reduce irradiation dose of normal lung for radiotherapy of lung cancer, we describe low-pulmonary functional area on 4-D CT in treatment planning.
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Selection of optimal functional lung imaging
Key secondary outcomes Establishment of new parameter for radiation pneumonitis based on functional lung

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1)Histologically or cytologically documentaed lung cancer
2) Age>=20 years of age and stage II-IIIB
3)Performance Status(ECOG)0-2
4)No prior radiotherapy or chemotherapy or operation or BRM
5)The patient willingly consent after being informed of the procedure.
Key exclusion criteria none
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoki Kimura
Organization Hiroshima University
Division name Department of radiation oncology
Zip code
Address 1-2-3 Kasumi Minami-ku Hiroshima City
TEL 082-257-1545
Email tkkimura@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoki Kimura
Organization Hiroshima University
Division name Department of radiation oncology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima City
TEL 082-257-1545
Homepage URL
Email tkkimura@hiroshima-u.ac.jp

Sponsor
Institute Department of radiation oncology, Hiroshima University
Institute
Department

Funding Source
Organization Japan Society of the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2010 Year 10 Month 01 Day

Related information
URL releasing protocol http://home.hiroshima-u.ac.jp/housya/
Publication of results Published

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
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 06 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 09 Month 30 Day

Other
Other related information We calculate new factors, such as Functional V20; FV20 and Functional mean lung dose;FMLD based on normal lung, and evaluate whether these factors can be prodict factors of radiation pneumonitis.

Management information
Registered date
2010 Year 09 Month 06 Day
Last modified on
2017 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004654

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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