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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038308
Receipt No. R000043661
Scientific Title Accelerated Partial Breast Irradiation with Intensity Modulation Radiotherapy (MRT) after Breast Conservative Surgery
Date of disclosure of the study information 2020/01/01
Last modified on 2020/04/16

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Basic information
Public title Accelerated Partial Breast Irradiation with Intensity Modulation Radiotherapy (MRT) after Breast Conservative Surgery
Acronym Accelerated Partial Breast Irradiation with IMRT
Scientific Title Accelerated Partial Breast Irradiation with Intensity Modulation Radiotherapy (MRT) after Breast Conservative Surgery
Scientific Title:Acronym Accelerated Partial Breast Irradiation with IMRT
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The standard method of the radiation therapy in the breast conservative therapy is whole breast irradiation, but another method is Accelerated Partial Breast Irradiation (APBI) which irradiate to tumor bed during short treatment period.
It is an advantages of APBI that improvement of adverse reaction and decrease of the going to hospital number of times
We perform APBI clinical trial by Volumetric-modulated arc therapy (V-MAT), and it is thought that it is important to confirm safety, the effectiveness.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of 2-year adverse events of grade 2 or worse
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Accelerated Partial Breast Irradiation (APBI)
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Female
Key inclusion criteria 1) Elderly patients aged between 50 and 80 years
2) Eastern Cooperative Oncology Group performance status
of 0 or 1
3) Pathological diameter of invasive or non invasive compon
ent =<2 cm
4) Invasive carcinoma or non invasive carcinoma
5) Single tumor
6) Positive estrogen receptor,
7) Distance between the surgical edge and cancer cell =>2
mm,
8) No axillary lymph node metastasis and
9) Written informed consent
Key exclusion criteria Active second malignancy, uncontrolled infection, pregnanc
y, mental disorder, uncontrolled diabetes mellitus, interstitial
pneumonitis, collagen vascular diseases, heart failure and pr
evious history of radiofrequency ablation.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Jiro
Middle name
Last name Kawamori
Organization St Luke's International Hospital
Division name Department of Radiation Oncology
Zip code 104-8560
Address 9-1 Akashucho Chuouku Tokyo
TEL 03-3541-5151
Email jirokawa@luke.ac.jp

Public contact
Name of contact person
1st name Jiro
Middle name
Last name Kawamori
Organization St Luke's International Hospital
Division name Department of Radiation Oncology
Zip code 104-8560
Address 9-1 Akashucho Chuouku Tokyo
TEL 03-3541-5151
Homepage URL
Email jirokawa@luke.ac.jp

Sponsor
Institute St Luke's International Hospital
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St Luke's International Hospital
Address 9-1 Akashucho Chuouku Tokyo
Tel 03-3541-5151
Email jirokawa@luke.ac.jp

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
2020 Year 01 Month 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 12 Month 01 Day
Date of IRB
2019 Year 10 Month 30 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2026 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 16 Day
Last modified on
2020 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043661

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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