Intraoperative Radiotherapy for Korean Patients With Breast Cancer

Yonsei University Health System (YUHS)

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Device: Intraoperative radiotherapy using Intrabeam®

Study type: Interventional

Funder types: Other

Identifiers

NCT02213991

K-IORT

Details and patient eligibility

About

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.

Full description

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

Enrollment: 215 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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215 participants in 1 patient group

Intraoperative Radiotherapy

Experimental group

Description:

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

Treatment:

Device: Intraoperative radiotherapy using Intrabeam®