breast cancer
Conditions
Interventions
Radiotherapy=Interstitial brachytherapy 36Gy/6fr/3-4 days Applicator implantation either at post-breast conserving surgery or at intra-breast conserving surgery
Sponsors
Oguchi Group, Grant for Cancer Research, Ministry of Health, Labour, and Welfare
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reproducibility of interstitial brachytherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| complication rates, local control rate, cosmetic results | — |
Countries
Japan
Contacts
Public ContactNOSE, Takayuki
Nippon Medical School Tamanagayama Hospital Department of Radiation Oncology
Outcome results
None listed