Intraoperative Radiotherapy for Korean Patients With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Gangnam Severance Hospital
Sponsor:
Information provided by (Responsible Party):
Joon Jeong, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT02213991
First received: August 5, 2014
Last updated: August 22, 2014
Last verified: August 2014
  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
Breast Conservative Surgery
Device: Intraoperative radiotherapy using Intrabeam®
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Gangnam Severance Hospital:

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

    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 ] [ Designated as safety issue: Yes ]
    Monitoring of local toxicity evaluated at 2 years and 5 years

  • Cosmesis [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    IBTR rate at 5 years

  • Dosimetray [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

    -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


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

Operation day

  • Breast conservative surgery + IORT (20 Gy)

Postoperative period

  • ± Chemotherapy
  • WBRT (46 Gy) for 4~5 weeks
  • ± Endocrine therapy or target therapy
Device: Intraoperative radiotherapy using Intrabeam®

Operation day

Breast conservative surgery + IORT (20 Gy) Postoperative period

  • Chemotherapy WBRT (46 Gy) for 4~5 weeks
  • Endocrine therapy or target therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02213991

Contacts
Contact: Joon Jeong, M.D.,Ph.D. 82220193370 gsjjoon@yuhs.ac
Contact: Sung Gwe Ahn, M.D. 82220194402 asg2004@yuhs.ac

Locations
Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135720
Sponsors and Collaborators
Gangnam Severance Hospital
  More Information

No publications provided

Responsible Party: Joon Jeong, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT02213991     History of Changes
Other Study ID Numbers: K-IORT
Study First Received: August 5, 2014
Last Updated: August 22, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on September 22, 2014