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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014825
Receipt No. R000017206
Scientific Title Evaluation of the feasibility of dynamic tumor-tracking irradiation without implanted fiducial marker based on 4D-CBCT.
Date of disclosure of the study information 2014/09/01
Last modified on 2019/02/16

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Basic information
Public title Evaluation of the feasibility of dynamic tumor-tracking irradiation without implanted fiducial marker based on 4D-CBCT.
Acronym Evaluation of the feasibility of dynamic tumor-tracking irradiation based on 4D-CBCT.
Scientific Title Evaluation of the feasibility of dynamic tumor-tracking irradiation without implanted fiducial marker based on 4D-CBCT.
Scientific Title:Acronym Evaluation of the feasibility of dynamic tumor-tracking irradiation based on 4D-CBCT.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the feasibility of the dynamic tumor-tracking irradiation without implanted fiducial markers by acquiring and analyzing 4-dimensional cone-beam CT (4D CB-CT) images.
Basic objectives2 Others
Basic objectives -Others Feasibility
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Feasibility of the dynamic tumor-tracking irradiation based on 4D-CBCT without fiducial marker.
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 Patients with early stage lung cancer (T1a-T2aN0M0) or 1-3 metastatic lung cancer who will be treated with dynamic tumor-tracking stereotactic body radiation therapy.
Key exclusion criteria Patients who do not agree with this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology & Image-applied Therapy
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3417
Email mizo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology & Image-applied Therapy
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3419
Homepage URL
Email mizo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Radiation Oncology & Image-applied Therapy
Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization non
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 京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.sciencedirect.com/science/article/pii/S0167814016312385?via%3Dihub
Number of participants that the trial has enrolled
Results
Target positions on inspiration phase were underestimated based on the reconstruction from 4DCBCT.
Radiat Oncol. 2018 Apr 19;13(1):73. doi: 10.1186/s13014-018-1019-9.
Radiother Oncol. 2016 Oct;121(1):46-51. doi: 10.1016/j.radonc.2016.07.022.
Epub 2016 Aug 12.
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
2014 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 05 Day
Last follow-up date
2017 Year 09 Month 16 Day
Date of closure to data entry
2017 Year 09 Month 16 Day
Date trial data considered complete
2017 Year 09 Month 16 Day
Date analysis concluded
2018 Year 09 Month 16 Day

Other
Other related information Details of the observation:
By acquiring and analyzing 4-dimensional cone-beam CT images, the feasibility of the dynamic tumor-tracking irradiation without implanted fiducial marker will be evaluated.

Management information
Registered date
2014 Year 08 Month 11 Day
Last modified on
2019 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017206

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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