UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000043661