UMIN-CTR Clinical Trial

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://center6.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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