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Intraoperative Radiotherapy for Korean Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT02213991
Recruitment Status : Active, not recruiting
First Posted : August 12, 2014
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Joon Jeong, Gangnam Severance Hospital

Tracking Information
First Submitted Date  ICMJE August 5, 2014
First Posted Date  ICMJE August 12, 2014
Last Update Posted Date February 15, 2018
Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2014)
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
A sample size of 195 achieves 80% power to detect a non-inferiority proportion (P0) of 0.2300 using a one-sided binomial test for non-inferiority. These results assume that the actual proportion (P1) is 0.1500. Considering a drop-out rate of 10%, the trial would need to enroll 215 patients in total. Expected number of patients with acute local toxicites associated with IORT-booster treatement is 32.
Change History Complete list of historical versions of study NCT02213991 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Radiotherapy for Korean Patients With Breast Cancer
Official Title  ICMJE A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Device: Intraoperative radiotherapy using Intrabeam®
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 9, 2014)
215
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213991
Other Study ID Numbers  ICMJE K-IORT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Joon Jeong, Gangnam Severance Hospital
Study Sponsor  ICMJE Gangnam Severance Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joon Jeong, M.D. Ph.D. Gangnam Severance Hospital
PRS Account Gangnam Severance Hospital
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP