UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035032
Receipt number 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 11:25:40

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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 or person

Institute

Asahi University

Institute

Department

Personal name



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

Value
https://center6.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