The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy for the replacement of boost-external beam radiotherapy in Korean women who are candidates for breast-conserving treatment.
Local toxicity checklist * Hematoma needing surgical evacuation * Seroma needing more than three aspirations * Skin breakdown or delayed wound healing * Any complication needing surgical intervention * Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other. * Any complication of RTOG toxicity grade more than 2
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
215
Operation day 1. Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. 2. Purse string suture pulles up tissues and wraps up the applicator. 3. Intraoperative radiotherapy using Intrabeam® (20Gy) is followed. 4. After IORT, applicator was out of the operative field, and usual wound closure will be done. * Postoperative period * Chemotherapy WBRT (46 Gy) for 4\~5 weeks * Endocrine therapy or target therapy
Gangnam Severance Hospital
Seoul, South Korea
Acute local toxicity in breast receiving IORT
Acute local toxicities of ipsilateral breast occurred within 6 months after IORT Local toxicity checklist * Hematoma needing surgical evacuation * Seroma needing more than three aspirations * Skin breakdown or delayed wound healing * Any complication needing surgical intervention * Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other. * Any complication of RTOG toxicity grade more than 2 Expected number of patients with acute local toxicites associated with IORT-booster treatement is 32. Considering a drop-out rate of 10%, the trial would need to enroll 215 patients in total.
Time frame: Up to 6 months
Delayed local toxicity
Monitoring of local toxicity evaluated at 2 years and 5 years
Time frame: Up to 5 years
Cosmesis
Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0
Time frame: Up to 2 years
Local tumor recurrence in ipsillateral breast
IBTR rate at 5 years
Time frame: Up to 5 years
Dosimetray
-Dosimetry in tumor cavity and correlation with acute and late complication rates * Identification of anatomical indication * MRI volumetry (Breast-to-tumor ratio) * Skin depth measured at preoperative US
Time frame: At time of surgery
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