Intraoperative Radiotherapy for Korean Patients With Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Intraoperative radiotherapy using Intrabeam®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed and newly diagnosed non-metastatic operable primary breast cancer Primary tumor <5cm, measured by ultrasonography - N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed) Age ≥18-years women with good performance status (ECOG 0-1) No breast operation is allowed except diagnostic biopsy Women with ductal carcinoma in situ diagnosed by preoperative biopsy are allowed Exclusion Criteria: Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential. Patients who received prior chemotherapy or radiotherapy for breast cancer Patients who have history of cancer other than in situ uterine cervix cancer or non-melanoma skin cancer The depth of tumor from skin measured by ultrasonography is less than 1cm. Contraindications to breast conservative surgery Multicentric breast cancer (tumors in more than one quadrant) Diffuse malignant appearing microcalcification Prior therapeutic radiation to the breast region Small breast, which is not possible to achieve clear margins in relation to a cosmetically acceptable result History of collagen vascular disease, such as active scleroderma and active lupus Postoperative exclusion Patients who require re-excision due to positive resection margin The depth of cavity from skin after lumpectomy is less than 0.5cm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Evaluate the safety of intraoperative radiotherapy using Intrabeam in Korean patients with early breast cancer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative Radiotherapy<br>Intervention: Intraoperative Radiotherapy * Operation day Breast conservative surgery + Intraoperative radiotherapy 20 Gy Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. Purse string suture pulles up tissues and wraps up the applicator. IORT with 20Gy is followed. 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 | Device: Intraoperative radiotherapy using Intrabeam®<br>* Operation day Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. Purse string suture pulles up tissues and wraps up the applicator. Intraoperative radiotherapy using Intrabeam® (20Gy) is followed. 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed local toxicity | Monitoring of local toxicity evaluated at 2 years and 5 years | Up to 5 years | 
| Cosmesis | Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0 | Up to 2 years | 
| Local tumor recurrence in ipsillateral breast | IBTR rate at 5 years | 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 | At time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Breast Conservative Surgery, Intraoperative Radiotherapy, Local Toxicity, Whole breast radiotherapy