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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001677
Receipt No. 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

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

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
URL(English) https://upload.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


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