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

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02927912

Patient View

This phase II trial evaluates the safety and efficacy of intraoperative electron beam radiotherapy boost in stage I-II breast cancer patients undergoing lumpectomy with reconstruction. It assesses grade 3 breast fibrosis, tumor recurrence, and cosmetic outcomes. Eligible patients must have node-negative cancer and meet specific health criteria. Interventions include IOERT, lumpectomy, reconstruction, and whole breast radiation.

Patient Parameters

Program Overview

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.

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.

Eligibility Criteria

Inclusion Criteria

  • Pathologically proven diagnosis of breast cancer

  • Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer

    • Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician

  • 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-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 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
  • 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

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