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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010848
Receipt No. R000012703
Official scientific title of the study Phase I/II clinical trial of radical radiotherapy using carbon-ion beams for early breast cancer
Date of disclosure of the study information 2013/05/31
Last modified on 2015/11/30

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Basic information
Official scientific title of the study Phase I/II clinical trial of radical radiotherapy using carbon-ion beams for early breast cancer
Title of the study (Brief title) Breast I (Protocol 1301)
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 and effectiveness of carbon ion radiotherapy for low risk stage I breast cancer, and to find optimal treatment dose.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes 1. Acute toxicities of normal tissue
2. Local control
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
Maneuver
Interventions/Control_1 Carbon ion radiotherapy 48 to 60GyE/4fr/4days
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
60 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Pathologically proven invasive ductal carcinoma.
2.Tumor 2 cm or less on MRI.
UICC clinical stage I.
3.Estrogen receptor positive, HER2 negative, No Lymphovascular space invasion, No extensive intraductal component
4.Performance status 0 to 2
5.Age 60 years old and over.
6.No other life-threatening illness
7.Written informed consent
Key exclusion criteria 1.Severe complication
2.Previous treatment
3.Active double primary
4.Tumor invasion to skin or chest wall
5.Distance between tumor border to skin less than 5mm.
6.Previous irradiation at tumor site
7. Non invasive ductal carcinoma
8. Medically, psychologically or other reason who are not suitable for candidate
Target sample size 20

Research contact person
Name of lead principal investigator Kumiko Karasawa
Organization National Institute of Radiological Sciences
Division name Research Center Hospital for Charged Particle Therapy National Institute of Radiological Sciences
Address 4-9-1 Anagawa, Inage-ku, Chiba-city,Chiba 263-8555 JAPAN
TEL 043-206-3306
Email kkarasaw@nirs.go.jp

Public contact
Name of contact person Kumiko Karasawa
Organization National Institute of Radiological Sciences
Division name Research Center Hospital for Charged Particle Therapy National Institute of Radiological Sciences
Address 4-9-1 Anagawa, Inage-ku, Chiba-city,Chiba 263-8555 JAPAN
TEL 043-206-3306
Homepage URL http://www.nirs.go.jp/hospital/index.shtml
Email kkarasaw@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

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 放射線医学総合研究所

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 31 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 05 Month 17 Day
Anticipated trial start date
2013 Year 05 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol http://www.nirs.go.jp/hospital/index.shtml
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2013 Year 05 Month 31 Day
Last modified on
2015 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012703

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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