Clinical trial NCT02213991: Intraoperative Radiotherapy for Korean Patients With Breast Cancer
Official title: A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Breast Conservative Surgery
Intraoperative Radiotherapy
Local Toxicity
Whole breast radiotherapy
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluate the safety of intraoperative radiotherapy using Intrabeam in Korean patients with early breast cancer.
Primary purpose: TREATMENT

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-conserving treatment.

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
* 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

Eligibility criteria: 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

Primary outcomes:
measure: Acute local toxicity in breast receiving IORT
timeFrame: Up to 6 months
Secondary outcomes:
measure: Delayed local toxicity
timeFrame: Up to 5 years
measure: Cosmesis
timeFrame: Up to 2 years
measure: Local tumor recurrence in ipsillateral breast
timeFrame: Up to 5 years
measure: Dosimetray
timeFrame: At time of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Joon Jeong, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahn SG, Bae SJ, Lee HW, Yoon CI, Kim JW, Lee IJ, Jeong J. A phase II study investigating the acute toxicity of targeted intraoperative radiotherapy as tumor-bed boost plus whole breast irradiation after breast-conserving surgery in Korean patients. Breast Cancer Res Treat. 2019 Feb;174(1):157-163. doi: 10.1007/s10549-018-5038-x. Epub 2018 Nov 22.