UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026080 |
|---|---|
| Receipt number | 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 17:04:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
radon@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
