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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030052
Receipt No. R000034298
Scientific Title A study to confirm the clinical criteria for boost irradiaion in breast conservertive radiotherapy
Date of disclosure of the study information 2018/06/01
Last modified on 2017/11/20

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Basic information
Public title A study to confirm the clinical criteria for boost irradiaion in breast conservertive radiotherapy
Acronym Retrospective analyses to confirm the clinical criteria for boost irradiaion in breast conservertive radiotherapy
Scientific Title A study to confirm the clinical criteria for boost irradiaion in breast conservertive radiotherapy
Scientific Title:Acronym Retrospective analyses to confirm the clinical criteria for boost irradiaion in breast conservertive radiotherapy
Region
Japan

Condition
Condition T1-2 Breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify a role of boost irradiation in breast conservertive irrad
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes local recurrence
Key secondary outcomes Implication of post-operative RT connected with endocrine therapy and young age etc.

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
25 years-old <=
Age-upper limit
85 years-old >
Gender Female
Key inclusion criteria between 25 and 84 years old females
patients with clinical stage T1-2 breast cancer
Key exclusion criteria M1 cases
cT3-4 stage or cN2-4 locally advanced cases
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyako Myojin
Organization Social care corporation Keiyukai sapporo
hospital
Division name Department of radiaion oncology
Zip code
Address Kita 1-1, Hondori 14 cho-me, Shiroishi-ku, SAPPORO
TEL 011-863-2101
Email miyako@keiyukaisapporo.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuo Hongo
Organization Social care corporation Keiyukai sapporo hospital
Division name Administrative office
Zip code
Address Kita 1-1, Hondori 14 cho-me, Shiroishi-ku, SAPPORO
TEL 011-863-2101
Homepage URL http://www.keiyukaisapporo.or.jp
Email nhongo@keiyukaisapporo.or.jp

Sponsor
Institute Social care corporation Keiyukai sapporo hospital
Institute
Department

Funding Source
Organization Social care corporation Keiyukai sapporo hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Shinsapporo breast clinic
Hokkaido cancer center department of radyiation oncolog
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 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
1997 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
1997 Year 06 Month 01 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 30 Day
Date trial data considered complete
2021 Year 06 Month 15 Day
Date analysis concluded
2021 Year 06 Month 30 Day

Other
Other related information A retrospective analysis for one arm treated with breast conservertive RT followed by boost RT following to boost criteria
about ipsilateral breast recurrence. The result is compared with historical control without any boost RT. Historical control cohort was treated in Hokkaido cancenter in which whole breast RT dose and methods were similar to the cohort group. Because when main resercher belonged to the cancer center,this RT protocole was compared with no boost protocole.

Management information
Registered date
2017 Year 11 Month 20 Day
Last modified on
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034298

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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