UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of accelerated partial breast irradiation using interstitial brachytherapy for female breast cancer <=3cm pN0M0
Title of the study (Brief title)	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	DOKIYA, Takushi
Organization	Saitama Medical University International Medical Center Comprehensive Cancer Center
Division name	Department of Radiation Oncology
Address	Yamane1397-1,Hidaka, Saitama, 350-1298, Japan
TEL	042-984-4136
Email	dokiya@saitama-med.ac.jp

Public contact
Name of contact person	NOSE, Takayuki
Organization	Nippon Medical School Tamanagayama Hospital
Division name	Department of Radiation Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 01 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000002025