UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001677
Receipt number R000002025
Scientific Title A feasibility study of accelerated partial breast irradiation using interstitial brachytherapy for female breast cancer <=3cm pN0M0
Date of disclosure of the study information 2009/02/01
Last modified on 2018/08/09 11:13:28

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Basic information

Public title

A feasibility study of accelerated partial breast irradiation using interstitial brachytherapy for female breast cancer <=3cm pN0M0

Acronym

APBI feasibility study

Scientific Title

A feasibility study of accelerated partial breast irradiation using interstitial brachytherapy for female breast cancer <=3cm pN0M0

Scientific Title:Acronym

APBI feasibility study

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate reproducibility of accelerated partial breast irradiation using interstitial brachytherapy in a multi-institutional setting to prepare for phase II and phase III study.

Basic objectives2

Others

Basic objectives -Others

reproducibility of interstitial brachytherapy in a multi-institutional setting

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

reproducibility of interstitial brachytherapy

Key secondary outcomes

complication rates, local control rate, cosmetic results


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

Radiotherapy=Interstitial brachytherapy 36Gy/6fr/3-4 days
Applicator implantation either at post-breast conserving surgery or at intra-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

35 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Eligibility criteria for implantation of post-BCS surgery
1)female breast cancer patients with a lesion <=3cm pN0M0 treated with breast conserving surgery
2)Unifocal and unicentric primary lesion
3)1 non-invasive ductal, 2invasive ductal, 3 mucinous, 4 medullary, 5 tubular carcinoma
4)no axillary node metastases, histologically confirmed
5)negative surgical margins, no exposure laterally and no exposure on skin side and muscle side
6)ER+ and/or PR+
7)at least 4 clips on surgical margins
8)breast specimen weighed
9)Four thru 16 wks post BCS at planned registration date
10)No prior chemotherapy nor no prior molecular targetting therapy
11)No breast cancer history nor no synchronous contralateral breast cancer
12)No distant metastases
13)With sufficient hemostatic function
14)Signed Informed consent for participation in the study
15)Patients' age older>= 35y.o.
16)performance Status: 0-1

Eligibility criteria for implantation of intra-BCS surgery

Should satisfy A)eligibility for intra-BCS applicator implantation operation, B)eligibility for actual applicator implantation during BCS, and C)eligibility for sole interstitial brachytherapy

Key exclusion criteria

1)Patients with Paget's disease
2)Patients with a breast unsatisfactory for brachytherapy
3)Patients who are pregnant or lactating
4)Patients with active collagen disease or history other than RA
5)patients with DM treated with continuous insulin or with uncontrolled DM
6)Patients with other active malignancy
7)Prior radiotherapy to chest region
8)Patients unsuitable for general anesthesia nor for local anesthesia
9)Patients with psychiatric disorders unsuitable for the study participation
10)Doctor in charge judged unsuitable for study participation

Target sample size

46


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name DOKIYA, Takushi

Organization

Saitama Medical University International Medical Center Comprehensive Cancer Center

Division name

Department of Radiation Oncology

Zip code


Address

Yamane1397-1,Hidaka, Saitama, 350-1298, Japan

TEL

042-984-4136

Email

dokiya@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name NOSE, Takayuki

Organization

Nippon Medical School Tamanagayama Hospital

Division name

Department of Radiation Oncology

Zip code


Address

Nagayama 1-7-1,Tama-city, Tokyo, 206-8512, Japan

TEL

042-371-2111

Homepage URL


Email

nose.apbi@gmail.com


Sponsor or person

Institute

Oguchi Group, Grant for Cancer Research, Ministry of Health, Labour, and Welfare

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour, and Welfare

Organization

Division

Category of Funding Organization

Non profit foundation

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

会津中央病院、大阪医療センター、川崎医科大学、癌研有明病院、九州医療センター、京都市立病院、国立がん研究センター中央病院、埼玉医科大学国際医療センター


Other administrative information

Date of disclosure of the study information

2009 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Forty-six eligible patients were registered. Among them, treatments for 43 patients were judged as reproducible. The result for the primary endpoint was thus concluded as reproducible. This result was approved by the assessment committee for effectiveness and safety on March 1, 2012.

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

Completed

Date of protocol fixation

2009 Year 01 Month 19 Day

Date of IRB


Anticipated trial start date

2009 Year 03 Month 01 Day

Last follow-up date

2016 Year 12 Month 01 Day

Date of closure to data entry

2016 Year 12 Month 01 Day

Date trial data considered complete

2016 Year 12 Month 01 Day

Date analysis concluded

2017 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 01 Month 31 Day

Last modified on

2018 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002025


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name