Status:
UNKNOWN
Intraoperative Radiotherapy for Korean Patients With Breast Cancer
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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-conserv...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT02213991
Start Date
August 1 2014
End Date
March 1 2020
Last Update
February 15 2018
Active Locations (1)
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1
Gangnam Severance Hospital
Seoul, South Korea, 135720