Intraoperative Radiotherapy for Korean Patients With Breast Cancer

NCT ID: NCT02213991

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2020-03-31

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraoperative Radiotherapy

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

Group Type: EXPERIMENTAL

Intraoperative radiotherapy using Intrabeam®

Intervention Type: DEVICE

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

Interventions

Intraoperative radiotherapy using Intrabeam®

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joon Jeong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joon Jeong, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Gangnam Severance Hospital

Locations

Gangnam Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30467660 (View on PubMed)

Other Identifiers

K-IORT

Identifier Type: -

Identifier Source: org_study_id