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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026080
Receipt No. R000029961
Scientific Title Verification of breath-hold technique in stereotactic body radiotherapy for lung cancer: what are the optimal margins?
Date of disclosure of the study information 2017/02/10
Last modified on 2019/02/12

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Basic information
Public title Verification of breath-hold technique in stereotactic body radiotherapy for lung cancer: what are the optimal margins?
Acronym Verification of breath-hold technique in stereotactic body radiotherapy for lung cancer
Scientific Title Verification of breath-hold technique in stereotactic body radiotherapy for lung cancer: what are the optimal margins?
Scientific Title:Acronym Verification of breath-hold technique in stereotactic body radiotherapy for lung cancer
Region
Japan

Condition
Condition primary stage I lung cancer or solitary metastatic lung cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the error and confirm the optimal margin in breath-hold technique in stereotactic body radiotherapy for lung cancer
Basic objectives2 Others
Basic objectives -Others To reduce the irradiated volume in stereotactic body radiotherapy for lung cancer, breath-hold techniques may be more convenient and effective than tracking or gating techniques. However, the optimal margin in the technique has not been established yet. In this prospective study, we will evaluate the optimal margin in breath-hold technique.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The reproducibility of breath-hold technique in stereotactic radiotherpay for lung cancer
Key secondary outcomes

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) primary stage I lung cancer or 3 or less metastatic lung cancer
2) the target respiratory motion was 10 mm or more
3) capability of 15 seconds or more breath-hold following our sign
4) consent has been obtained from them
Key exclusion criteria 1) arteriovenous fistulae of the lung
2) uncontrollable bleeding disorder
3) diagnosed psychiatric
4) pregnant
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taro Murai
Organization Nagoya City University
Division name Radiology
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi Prefecture, 467-8601 JAPAN
TEL 052-853-8276
Email radon@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taro Murai
Organization Nagoya City University
Division name Radiology
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi Prefecture, 467-8601 JAPAN
TEL 052-853-8276
Homepage URL
Email radon@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University
Institute
Department

Funding Source
Organization no
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
2017 Year 02 Month 10 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
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information no

Management information
Registered date
2017 Year 02 Month 10 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029961

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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