Clinical Trials /

Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

NCT01960803

Description:

The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
  • Official Title: Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: ACI-001
  • NCT ID: NCT01960803

Conditions

  • Invasive Ductal Breast Cancer
  • Carcinoma Breast Stage I

Purpose

The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.

Detailed Description

      Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation
      of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the
      patient, are evaluated using questionnaire.

      Local recurrence is evaluated under the same imaging protocol used for Whole breast
      radiation.
    

Trial Arms

NameTypeDescriptionInterventions
IOERT armExperimentalIntraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room. This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV. The radiation is delivered from the device to the tumor bed through an attached applicator. A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Patient agrees to breast conservation therapy (segmental resection, partial
                 mastectomy, and radiation therapy) as the treatment for their breast cancer
    
              -  Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
    
              -  Post-menopausal women age > 60, defined as women who have experienced no menstrual
                 period in the past 6 months or more
    
              -  BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based
                 upon personal or family history]
    
              -  Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous,
                 tubular, colloid) < 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
    
              -  Grade 1, 2, or 3 acceptable
    
              -  Associated LCIS is allowed
    
              -  Estrogen receptor (ER) status of positive
    
              -  Patient has clear margins >2 mm on gross pathologic examination
    
              -  Patient is node-negative, defined as N0 (i-) or N0 (i+)
    
              -  Patient must be deemed functionally and mentally competent to understand and sign the
                 informed consent
    
            Exclusion Criteria:
    
              -  Prior breast malignancy or other malignancy if metastatic, or with expected survival
                 of < 5 years
    
              -  Immunocompromised status
    
              -  Pregnancy
    
              -  Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
    
              -  Breast cancer that involves the skin or chest wall, locally advanced breast cancer
    
              -  Pure DCIS, all grades
    
              -  Invasive lobular carcinoma
    
              -  Evidence of lymphovascular invasion (LVI)
    
              -  Invasive carcinoma with extensive intraductal component (EIC)
    
              -  Neoadjuvant chemotherapy
    
              -  Patients with 1 or more positive lymph node determined during surgery with sentinel
                 node and/or axillary dissection
    
              -  Someone who is not a candidate for breast conserving management, i.e., prior whole
                 breast radiation therapy
          
    Maximum Eligible Age:95 Years
    Minimum Eligible Age:60 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:To evaluate the overall incidence of local and distance recurrence rates.
    Time Frame:5 years
    Safety Issue:
    Description:Subjects will be followed at one month, six months, and then once every six months until five years and then yearly up to 10 years.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Advocate Health Care

    Trial Keywords

    • Stage I Breast Carcinoma

    Last Updated

    November 6, 2016