Unique ID issued by UMIN | UMIN000001677 |
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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 |
A feasibility study of accelerated partial breast irradiation using interstitial brachytherapy for female breast cancer <=3cm pN0M0
APBI feasibility study
A feasibility study of accelerated partial breast irradiation using interstitial brachytherapy for female breast cancer <=3cm pN0M0
APBI feasibility study
Japan |
breast cancer
Breast surgery | Radiology |
Malignancy
NO
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.
Others
reproducibility of interstitial brachytherapy in a multi-institutional setting
Exploratory
Not applicable
reproducibility of interstitial brachytherapy
complication rates, local control rate, cosmetic results
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Radiotherapy=Interstitial brachytherapy 36Gy/6fr/3-4 days
Applicator implantation either at post-breast conserving surgery or at intra-breast conserving surgery
35 | years-old | <= |
Not applicable |
Female
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
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
46
1st name | |
Middle name | |
Last name | DOKIYA, Takushi |
Saitama Medical University International Medical Center Comprehensive Cancer Center
Department of Radiation Oncology
Yamane1397-1,Hidaka, Saitama, 350-1298, Japan
042-984-4136
dokiya@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | NOSE, Takayuki |
Nippon Medical School Tamanagayama Hospital
Department of Radiation Oncology
Nagayama 1-7-1,Tama-city, Tokyo, 206-8512, Japan
042-371-2111
nose.apbi@gmail.com
Oguchi Group, Grant for Cancer Research, Ministry of Health, Labour, and Welfare
Ministry of Health, Labour, and Welfare
Non profit foundation
NO
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
2009 | Year | 02 | Month | 01 | Day |
Published
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.
Completed
2009 | Year | 01 | Month | 19 | Day |
2009 | Year | 03 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2017 | Year | 02 | Month | 01 | Day |
2009 | Year | 01 | Month | 31 | Day |
2018 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002025
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