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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016206
Receipt No. R000018796
Official scientific title of the study A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer
Date of disclosure of the study information 2015/01/13
Last modified on 2017/07/24

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Basic information
Official scientific title of the study A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer
Title of the study (Brief title) A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer
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 proton therapy 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 Proton therapy 60 to 72GyE/10Fr/12days
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
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Pathologically proven invasive ductal carcinoma(normal type).
2.Tumor size is 2cm or less on MRI.UICC clinical stageI(T1N0M0)
3. No Lymphovascular space invasion(LVSI), No extensive intraductal component(EIC),Estrogen receptor positive.
4.Performance status 0 to 2.
5.Age 50 years old and over.
6.No other life-threatening illness.
7.Surgery is difficult,surgery has denied herself.
8.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 1cm on MRI.
6.Previous irradiation at tumor site
7. Non invasive ductal carcinoma (pure DCIS)
8. Medically, psychologically or other reason who are not suitable for candidate.
9. History of connective tissue diseases
Target sample size 20

Research contact person
Name of lead principal investigator Hiroyasu Tamamura
Organization Fukui Prefectural Hospital
Division name Proton Therapy Center
Address 2-8-1 Yotsu,Fukui city,Fukui Prefecture,910-8526 Japan
TEL 0776-54-5151
Email h-tamamura-8e@pref.fukui.lg.jp

Public contact
Name of contact person Yoshitaka Sato
Organization Fukui Prefectural Hospital
Division name Proton Therapy Center
Address 2-8-1 Yotsu,Fukui city,Fukui Prefecture,910-8526 Japan
TEL 0776-54-5151
Homepage URL
Email y-satou-xn@pref.fukui.lg.jp

Sponsor
Institute Fukui Prefectural Hospital
Institute
Department

Funding Source
Organization FukuiPrefecture
Organization
Division
Category of Funding Organization Local Government
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 福井県立病院(福井県)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 13 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 10 Month 21 Day
Anticipated trial start date
2015 Year 01 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2015 Year 01 Month 13 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018796

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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