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Intraoperative Radiotherapy for Korean Patients With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02213991
First Posted: August 12, 2014
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joon Jeong, Gangnam Severance Hospital
  Purpose
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.

Condition Intervention Phase
Breast Cancer Device: Intraoperative radiotherapy using Intrabeam® Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Evaluate the safety of intraoperative radiotherapy using Intrabeam in Korean patients with early breast cancer.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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

Resource links provided by NLM:


Further study details as provided by Joon Jeong, Gangnam Severance Hospital:

Primary Outcome Measures:
  • Acute local toxicity in breast receiving IORT [ Time Frame: Up to 6 months ]

    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 [ Time Frame: Up to 5 years ]
    Monitoring of local toxicity evaluated at 2 years and 5 years

  • Cosmesis [ Time Frame: Up to 2 years ]
    Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0

  • Local tumor recurrence in ipsillateral breast [ Time Frame: Up to 5 years ]
    IBTR rate at 5 years

  • Dosimetray [ Time Frame: At time of surgery ]

    -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


Enrollment: 215
Study Start Date: August 2014
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Device: 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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213991


Locations
Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135720
Sponsors and Collaborators
Gangnam Severance Hospital
Investigators
Principal Investigator: Joon Jeong, M.D. Ph.D. Gangnam Severance Hospital
  More Information

Responsible Party: Joon Jeong, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT02213991     History of Changes
Other Study ID Numbers: K-IORT
First Submitted: August 5, 2014
First Posted: August 12, 2014
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Joon Jeong, Gangnam Severance Hospital:
Breast Cancer
Breast Conservative Surgery
Intraoperative Radiotherapy
Local Toxicity
Whole breast radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases