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Breast CancerPhase 2NCT02213991

Intraoperative Radiotherapy for Korean Patients With Breast Cancer

A Phase 2 study testing Intraoperative radiotherapy using Intrabeam® in people with Breast Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Intraoperative radiotherapy using Intrabeam®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
1 siteSouth Korea
Study dates
Aug 2014to Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Gangnam Severance Hospital

    Seoul, 135720

Other trials in South Korea

About this study

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

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.

Read the 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
Being tested
Intraoperative radiotherapy using Intrabeam®
Keywords
Breast Cancer, Breast Conservative Surgery, Intraoperative Radiotherapy, Local Toxicity, Whole breast radiotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoperative radiotherapy using Intrabeam®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
Study groups in NCT02213991
Study groupRoleWhat they receive
Intraoperative RadiotherapyExperimentalIntervention: 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
Receives: Device: Intraoperative radiotherapy using Intrabeam®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 6 months

Secondary outcomes (4)

  1. Delayed local toxicity

    Monitoring of local toxicity evaluated at 2 years and 5 years

    Measured: Up to 5 years

  2. Cosmesis

    Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0

    Measured: Up to 2 years

  3. Local tumor recurrence in ipsillateral breast

    IBTR rate at 5 years

    Measured: Up to 5 years

  4. 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

    Measured: At time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionOct 2017
  4. Study completionMar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Evaluate the safety of intraoperative radiotherapy using Intrabeam in Korean patients with early breast cancer.
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02213991
Sponsor's protocol ID
K-IORT
Status last verified
Feb 2018
First submitted
5 Aug 2014
Last updated
15 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Baek SH, Bae SJ, Kook Y, Cho Y, Ahn SG, Kim JW, Lee IJ, Jeong J. Long-term oncologic outcome of intraoperative radiotherapy (IORT) with low-energy X-rays as a tumor-bed boost in Korean patients with breast cancer. Cancer Treat Res Commun. 2025;43:100925. doi: 10.1016/j.ctarc.2025.100925. Epub 2025 Apr 14.

    PubMed 40252397

  • 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.

    PubMed 30467660

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intraoperative radiotherapy using Intrabeam® in people with Breast Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute local toxicity in breast receiving IORT (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02213991, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.

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