UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030052 |
|---|---|
| Receipt number | 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 22:00:43 |
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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
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
nhongo@keiyukaisapporo.or.jp
Sponsor or person
Institute
Social care corporation Keiyukai sapporo hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
