UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010848
Receipt number R000012703
Scientific Title 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 17:06:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Phase I/II clinical trial of radical radiotherapy using carbon-ion beams for early breast cancer

Acronym

Breast I (Protocol 1301)

Scientific Title

Phase I/II clinical trial of radical radiotherapy using carbon-ion beams for early breast cancer

Scientific Title:Acronym

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

1st name
Middle name
Last name Kumiko Karasawa

Organization

National Institute of Radiological Sciences

Division name

Research Center Hospital for Charged Particle Therapy National Institute of Radiological Sciences

Zip code


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

1st name
Middle name
Last name Kumiko Karasawa

Organization

National Institute of Radiological Sciences

Division name

Research Center Hospital for Charged Particle Therapy National Institute of Radiological Sciences

Zip code


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 or person

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name



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)



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

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


Related information

URL releasing protocol

http://www.nirs.go.jp/hospital/index.shtml

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

Open public recruiting

Date of protocol fixation

2013 Year 05 Month 17 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012703


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name