Clinical Trials /

Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction

NCT02927912

Description:

This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
  • Official Title: Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: OSU-16106
  • SECONDARY ID: NCI-2016-01294
  • NCT ID: NCT02927912

Conditions

  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer

Purpose

This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the rate of grade 3 breast fibrosis at 1 year in women undergoing lumpectomy
      with oncoplastic reconstruction and immediate intraoperative electron radiotherapy boost
      followed by adjuvant whole breast radiotherapy.

      SECONDARY OBJECTIVES:

      I. To determine the rate of 5 year ipsilateral breast tumor recurrence rate. II. To
      determine the change in self-reported cosmesis using the Breast Cancer Treatment Outcome
      Scale (BCTOS) questionnaire.

      III. To evaluate physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis
      Scale and digital photographs.

      OUTLINE:

      Patients undergo standard of care lumpectomy and then undergo 1 fraction of intraoperative
      electron beam radiation therapy (IOERT) boost to the lumpectomy cavity. Patients then
      undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.

      After completion of study treatment, patients are followed up at 1 month, 6 months, 1 year,
      and every year thereafter for 5 years.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (IOERT boost)ExperimentalPatients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Pathologically proven diagnosis of breast cancer
    
              -  Clinical stage I or II
    
              -  Multifocal breast cancer is allowed if the intent is to undergo resection through a
                 single lumpectomy incision
    
              -  Axilla must be staged by one of the following
    
                   -  Sentinel node biopsy alone (if sentinel node is negative)
    
                   -  Sentinel node biopsy alone OR followed by axillary dissection per investigator
                      discretion for clinically node negative patients as defined below:
    
                        -  Microscopic sentinel node positive (pN1mic)
    
                        -  One or two sentinel nodes positive (pN1) without extracapsular extension
    
                   -  Axillary node dissection is required following sentinel node biopsy with a
                      minimum total of 6 axillary nodes if any of the following exist:
    
                        -  3 or more positive sentinel nodes
    
                        -  Extracapsular extension
    
                   -  Axillary dissection alone (minimum of 6 nodes)
    
              -  Appropriate stage for protocol entry including no clinical evidence for distant
                 metastases based upon the following minimum diagnostic workup
    
              -  History/physical examination, documentation of weight and Zubrod performance status
                 0-2 within 28 days prior to study entry
    
              -  Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
    
              -  Absolute neutrophil count > 1800 cells/cubic mm
    
              -  Platelets >= 75,000 cells/cubic mm
    
              -  Hemoglobin >= 8 g/dL
    
              -  Women of childbearing potential must have a negative urine or serum pregnancy test
                 within 14 days of study entry
    
              -  Women of childbearing potential must be non-pregnant and non-lactating and willing to
                 use medically acceptable form of contraception during radiation therapy
    
              -  Patients must provide study specific informed consent prior to study entry
    
            Exclusion Criteria:
    
              -  Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
    
              -  Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma
                 in situ of the cervix) unless disease free for a minimum of 5 yrs prior to study
                 entry
    
              -  Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in
                 situ [LCIS] is eligible)
    
              -  Two or more cancers not resectable through a single lumpectomy incision
    
              -  Bilateral breast cancer
    
              -  Ductal breast carcinoma in situ (DCIS) only
    
              -  Non-epithelial breast malignancies such as sarcoma/lymphoma
    
              -  Male breast cancer
    
              -  Paget's disease of the nipple
    
              -  Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral
                 breast that would result in overlap of radiation fields
    
              -  Intention to administer neoadjuvant chemotherapy prior to resection
    
              -  Severe active comorbidity defined as follows:
    
                   -  Unstable angina and/or congestive heart failure requiring hospitalization within
                      the last 6 months
    
                   -  Transmural myocardial infarction within the last 6 months
    
                   -  Acute bacterial or fungal infection requiring intravenous antibiotics at the
                      time of registration
    
                   -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                      requiring hospitalization or precluding study therapy within 30 days before
                      registration
    
                   -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
                      note, however, that laboratory tests for liver function and coagulation
                      parameters are not required for entry into this protocol
    
                   -  Acquired immune deficiency syndrome (AIDS) based upon current Centers for
                      Disease Control and Prevention (CDC) definition; note, however, that human
                      immunodeficiency virus (HIV) testing is not required for entry into this
                      protocol
    
              -  Pregnancy or women of childbearing potential who are sexually active and not
                 willing/able to use medically acceptable forms of contraception
    
              -  Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis
                 with active rash
    
              -  Medical, psychiatric or other condition that would prevent the patient from receiving
                 the protocol therapy or providing informed consent
          
    Maximum Eligible Age:59 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
    Time Frame:Up to 30 days after surgery and IOERT boost
    Safety Issue:
    Description:If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.

    Secondary Outcome Measures

    Measure:Change in self-reported cosmesis using the BCTOS
    Time Frame:Baseline up to 3 years
    Safety Issue:
    Description:The mean and standard deviation of the self-reported cosmesis using the BCTOS cosmesis scale will be summarized over time. The change over time using a repeated measures model or non-parametric methods, if appropriate, will be examined.
    Measure:Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs
    Time Frame:Up to 3 years after completion of radiation therapy
    Safety Issue:
    Description:physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs
    Measure:Quality of life assessed by Breast Cancer Treatment Outcome Scale
    Time Frame:Up to 3 years after completion of radiation therapy
    Safety Issue:
    Description:determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT
    Measure:Rate of ipsilateral breast tumor recurrence
    Time Frame:At 5 years
    Safety Issue:
    Description:The exact binomial confidence interval for the rate will be calculated.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Ohio State University Comprehensive Cancer Center

    Last Updated

    March 29, 2017