Clinical Trials /

Node Negative, Invasive Breast Cancer Single Fraction IOERT

NCT02370797

Description:

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Node Negative, Invasive Breast Cancer Single Fraction 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-1450-IOERTSFX
  • NCT ID: NCT02370797

Conditions

  • Breast Cancer

Purpose

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

Detailed Description

      See points VIII inclusion/exclusion criteria

      Operation:

        -  Lumpectomy, steninal node biopsy

        -  IOeRT

      After Surgery:

        -  Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is
           recommended as part of your treatment course. In some cases, pathology results may
           indicate the need for removal of additional lymph nodes. The doctor will review
           pathology and discuss if additional surgery is required.

        -  Chemotherapy (if indicated)

        -  Hormone therapy (if indicated)

      Follow-Up

        -  Visits will be completed with the surgeon, radiation oncologist and research staff as
           the protocol indicates.

        -  Assessements of acute toxicity according to CTC-toxicity scoring system

        -  Assessments of late toxicity according to LENT-SOMA scoring systems

        -  Assessment of cosmetic outcome according to scoring system and photo documentation in
           standardized positions.
    

Trial Arms

NameTypeDescriptionInterventions
Single Fraction IOeRTExperimentalA single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.

    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 12 months.
    
              -  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 acceptable
    
              -  Associated LCIS is allowed
    
              -  Estrogen receptor (ER) status of positive
    
              -  Negative margins at ink 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
    
              -  Immuno-compromised 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 indicated
    
              -  Patients with 1 or more positive lymph node determined during surgery with sentinel
                 node and/or axillary dissection
    
              -  Not eligible for breast conserving management, i.e., prior whole breast radiation
                 therapy
    
              -  Estrogen receptor negative
    
              -  Her2 positive
    
              -  Grade 3
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:60 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Proportion of patients who are free of breast cancer.
    Time Frame:10 years
    Safety Issue:
    Description:Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.

    Secondary Outcome Measures

    Measure:Local recurrance rate with acute toxicity and cosmetic evaluations
    Time Frame:10 years
    Safety Issue:
    Description:AEs and Lent Soma will be assessed for acute toxicity. We will use a 20% toxicity cutoff, the protocol would be stopped if 2/10 were determined to have developed significant toxicities, grade 3 or greater, at the first 6-month follow-up visit. 2/10 patients at 6-months follow-up, 4/20 patients at 1-year follow-up, 6/30 at 18-months follow-up, 8/40 at 24-months follow-up, 10/50 at 30-months follow-up, 12/60 at 36-months follow-up, 14/70 at 42-months follow-up, 16/80 at 48-months follow-up, 18/90 at 54-months and 20/100 at 60-months follow-up. Cosmetic evaluations will be completed by the patient and radiation oncologist an via breast exams, questionnaires and breast photo documentation.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Avera McKennan Hospital & University Health Center

    Trial Keywords

    • IOERT
    • Radiation
    • Single fraction
    • Lumpectomy
    • Radiation therapy
    • Avera

    Last Updated

    June 22, 2016