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Intraoperative Radiotherapy for Korean Patients With Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intraoperative radiotherapy using Intrabeam®
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Breast Conservative Surgery, Intraoperative Radiotherapy, Local Toxicity, Whole breast radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative Radiotherapy

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Delayed local toxicity
Monitoring of local toxicity evaluated at 2 years and 5 years
Cosmesis
Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0
Local tumor recurrence in ipsillateral breast
IBTR rate at 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

Full Information

First Posted
August 5, 2014
Last Updated
February 13, 2018
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02213991
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Breast Conservative Surgery, Intraoperative Radiotherapy, Local Toxicity, Whole breast radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Evaluate the safety of intraoperative radiotherapy using Intrabeam in Korean patients with early breast cancer.
Masking
None (Open Label)
Allocation
N/A
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative Radiotherapy
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Intraoperative radiotherapy using Intrabeam®
Intervention Description
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
Primary Outcome Measure Information:
Title
Acute local toxicity in breast receiving IORT
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Delayed local toxicity
Description
Monitoring of local toxicity evaluated at 2 years and 5 years
Time Frame
Up to 5 years
Title
Cosmesis
Description
Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0
Time Frame
Up to 2 years
Title
Local tumor recurrence in ipsillateral breast
Description
IBTR rate at 5 years
Time Frame
Up to 5 years
Title
Dosimetray
Description
-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
Time Frame
At time of surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon Jeong, M.D. Ph.D.
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135720
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30467660
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.
Results Reference
derived

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Intraoperative Radiotherapy for Korean Patients With Breast Cancer

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