UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost in Breast conserving therapy
Acronym	A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost
Scientific Title	A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost in Breast conserving therapy
Scientific Title:Acronym	A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety of hypofractionated whole breast irradiation with concurrent boost in breast conserving treatment.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	proportion of acute adverse events
Key secondary outcomes	proportion of late adverse events, proportion of deterioration of breast cosmetic 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 Maneuver
Interventions/Control_1	Hypofractionated whole breast irradiation therapy (43.2Gy/18fr) with concurrent boost (50.4Gy/18fr) after breast conserving surgery
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	Not applicable
Gender	Female
Key inclusion criteria	Patients must fulfill all of the following conditions 1) clinical stage I, II 2) pathologically proven diagnosis of invasive ductal carcinoma, or specific type of carcinoma 3) positive resection margin or close resection margin within 5mm 4) Aged 20 years old or more 5) breast conserving surgery 6) inserted surgical clips in tumor resection margin or mark indicating the resection margin on the skin 7) whole breast irradiation without regional (supraclavicular or parasternal) nodal irradiation planned 8) no prior radiation therapy to thoracic 9) performance status (ECOG) of 0 or 1 10) written informed consent 11) oriental women with enough fluency in Japanese
Key exclusion criteria	1) Prior invasive non-breast malignancy (except carcinoma in situ) unless disease free for a minimum of 5 years prior to study entry 2) Metachronous or simultaneous bilateral breast cancers 3) Acute infection requiring systemic therapy 4) Body temperature 38 degrees Celsius or more at registration 5) Psychiatric or other condition that would prevent the patient from receiving the protocol therapy 6) Uncontrollable diabetes mellitus or administration of insulin 7) Active or prior history of scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis 8) Systemic steroids or immunosuppressant medication 9) Severe heart failure or angina attack or myocardial infarction within the last 6 months 10) Interstitial pneumonia, pulmonary fibrosis, or severe chronic obstructive pulmonary disease 11) Pregnancy, pregnancy potential, after giving birth within 28 days, or lactating
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiro Hiraoka
Organization	Graduate school of Medicine, Kyoto University
Division name	Department of Radiation Oncology and Image-applied Therapy
Zip code
Address	54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL	0753667654
Email	hiraok@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Michio Yoshimura
Organization	Graduate school of Medicine, Kyoto University
Division name	Department of Radiation Oncology and Image-applied Therapy
Zip code
Address	54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL	0753667654
Homepage URL
Email	myossy@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University Hospital
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
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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 10 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	No longer recruiting
Date of protocol fixation	2015 Year 09 Month 01 Day
Date of IRB	2015 Year 09 Month 24 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2020 Year 09 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 07 Day
Last modified on	2020 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021088