UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006474
Receipt number R000007617
Scientific Title A clinical study on the safety and efficacy of accelerated partial breast irradiation in breast-conserving therapy
Date of disclosure of the study information 2011/12/01
Last modified on 2013/10/04 11:42:51

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Basic information

Public title

A clinical study on the safety and efficacy of accelerated partial breast irradiation in breast-conserving therapy

Acronym

Accelerated partial breast irradiation in breast-conserving therapy

Scientific Title

A clinical study on the safety and efficacy of accelerated partial breast irradiation in breast-conserving therapy

Scientific Title:Acronym

Accelerated partial breast irradiation in breast-conserving therapy

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 efficacy of radiation therapy (38.5Gy /10fr /2 weeks) using 3D-CRT to a limited volume around the tumor bed after breast-conserving surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

proportion of grade 3 or higher acute or late adverse events within 2 years.

Key secondary outcomes

ipsilateral breast recurrence-free survival, proportion of protocol treatment completion, proportion of deterioration of breast cosmetic outcomes, disease-free survival, overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

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

Radiation therapy (38.5Gy /10fr /2 weeks) to the tumor bed region 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

40 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients must fulfill all of the following conditions
1) clinical stage 0, I, II excluding T3 breast cancer with 3 cm or less histological tumor diameter.
2) Histologically confirmed ductal carcinoma in situ (DCIS), invasive ductal carcinoma, or specific type of carcinoma.
3) No tumor cells within 5 mm from the surgical margin in the histological specimens.
4) Single primary tumor.
5) Aged 40 years old or more.
6) No prior chemotherapy or hormonal therapy.
7) Breast-conserving surgery with lumpectomy or segmental mastectomy. Re-excision is permitted if clips are inserted in the final resection margin.
8) Inserted surgical clips in tumor resection margin.
9) Axillary lymph node dissection with level I or II, or histologically negative sentinel lymph nodes. allowance for no axillary dissection in DCIS
10) Three or less positive axillary lymph nodes including sentinel lymph nodes.
11) No prior radiation therapy against the thoracic.
12) Performance status of 0 or 1.
13) Written informed consent.
14) Asian woman with enough fluency in Japanese.

Key exclusion criteria

1) Simultaneous or metachronous (within 5 years) double cancers.
2) Metachronous or simultaneous bilateral breast cancers
3) Infection with systemic therapy indicated.
4) Body temperature of 38 or more degrees Celsius.
5) Psychosis.
6) Uncontrollable diabetes mellitus or administration of insulin.
7) Scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis.
8) Systemic steroids medication.
9) Immunosuppressant for active collagen disease.
10) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.
11) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
12) Women during pregnancy, possible pregnancy or breast-feeding.

Target sample size

50


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

0757513417

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

0757513762

Homepage URL


Email

myossy@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



Funding Source

Organization

Funding Program for World-Leading Innovative R&D on Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor

Mitsubishi heavy industries, Ltd.

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

2011 Year 12 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

No longer recruiting

Date of protocol fixation

2011 Year 11 Month 04 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 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

2011 Year 10 Month 04 Day

Last modified on

2013 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007617


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name