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

UMIN ID: UMIN000001677

Registered date:01/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 2009/03/01
• Target sample size: 46
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Radiotherapy=Interstitial brachytherapy 36Gy/6fr/3-4 days Applicator implantation either at post-breast conserving surgery or at intra-breast conserving surgery

Outcome(s)

• Primary Outcome: reproducibility of interstitial brachytherapy
• Secondary Outcome: complication rates, local control rate, cosmetic results

Key inclusion & exclusion criteria

• Age minimum: 35years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Oguchi Group, Grant for Cancer Research, Ministry of Health, Labour, and Welfare
• Source(s) of Monetary Support: Ministry of Health, Labour, and Welfare