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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000035032
Receipt No. R000039943
Scientific Title Comparison between IMRT and VMAT of radiotherapy in breast conserving therapy
Date of disclosure of the study information 2018/11/27
Last modified on 2019/06/29

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Basic information
Public title Comparison between IMRT and VMAT of radiotherapy in breast conserving therapy
Acronym Comparison between IMRT and VMAT of radiotherapy in breast conserving therapy
Scientific Title Comparison between IMRT and VMAT of radiotherapy in breast conserving therapy
Scientific Title:Acronym Comparison between IMRT and VMAT of radiotherapy in breast conserving therapy
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Whether which IMRT method or VMAT method is useful is compared with simulation on the computer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Which dose is uniform in IMRT and VMAT and the dose to the heart can be suppressed
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
90 years-old >
Gender Female
Key inclusion criteria The patients who took breast conserving therapy
Key exclusion criteria The patients who took mastectomy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kousei Ono
Organization Asahi University
Division name Division of Radiation Serivice
Zip code
Address 3-23 Hashimoto-cho gifu gifu Japan
TEL 81582538001
Email kouseixgo@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kousei Ono
Organization Asahi University
Division name Division of Radiation Service
Zip code
Address 3-23 Hashimoto-cho gifu gifu Japan
TEL 81582538001
Homepage URL
Email kouseixgo@gmail.com

Sponsor
Institute Asahi University
Institute
Department

Funding Source
Organization Asahi University
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
2018 Year 11 Month 27 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 Main results already published
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 03 Month 04 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2019 Year 05 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2019 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039943

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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