Over the past two decades, breast conserving therapy (BCT) has become a major treatment modality for Stage I and II breast carcinoma. The major advantages of breast conserving therapy are superior cosmetic outcome and the reduced emotional and psychological trauma afforded by this procedure compared with conventional mastectomy. The principal disadvantage of BCT is its more complex and prolonged treatment regimen requiring approximately 6 weeks of external beam radiation therapy that poses problems for some patients such as the working woman, elderly patients, and those who live at a significant distance from a treatment center. These factors, along with the patient's geographic location, result in a smaller fraction of the patients who currently meet eligibility criteria for BCT actually receiving it, despite its cosmetic and probable psychological advantages. The logistical problems of BCT are primarily related to the protracted course of external beam radiation therapy to the whole breast. While some investigators reported what they believe to be acceptable local control rates in carefully selected patients treated by wide local excision without radiation therapy, the criteria for patient selection are controversial and poorly defined and probably restrict the access of many patients to breast conserving therapy. If previous observations are valid and breast irradiation following tylectomy exerts its maximal effect in eradicating occult disease remaining in the immediate vicinity of the tylectomy site, can radiation therapy be directed only to the tissue surrounding the excision cavity of the breast, using brachytherapy alone? If so, the entire course of radiation therapy could be delivered over a 4 to 7 day period immediately following tylectomy and/or axillary dissection, thus markedly reducing treatment time. Brachytherapy also inherently provides a higher central dose to the volume most at risk for recurrence. Cosmetic outcome after the use of a brachytherapy boost after external whole breast radiotherapy is comparable or slightly inferior to electron beam boost radiation therapy
This study will evaluate the local control, cosmetic results, quality of life, and complication rates of brachytherapy when used as the sole method of radiation therapy for patients with stage 0,I, and II carcinoma of the breast treated with tylectomy, with histologically assessed negative surgical margins, N0 axillary nodes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
151
brachytherapy (radioactive implants)
Washington University School of Medicine
St Louis, Missouri, United States
Local Control Using Ipsilateral Breast Tumor Recurrence Rates
Time frame: 2 years after treatment completion
Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates
Time frame: 5 years after treatment completion
Local Control Using Disease-free Survival Rates
Time frame: 2 years after treatment completion
Local Control Using Disease-free Survival Rates
Time frame: 5 years after treatment completion
Quality of Life Completion
-QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC breast cancer module QLQ-BR23 questionnaires. QLQ-C30 is composed of 30 questions. QLQ-BR23 consists of 23 questions.
Time frame: 2 years
Excellent-good Cosmetic Outcomes - Patient Reported
* Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. * The global cosmetic result were scored on a 4-point scare where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference).
Time frame: 3 years after completion of therapy
Excellent-good Cosmetic Outcomes - Physician Reported
* Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA). * The global cosmetic result were scored on a 4-point scale where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference).
Time frame: 3 years after completion of therapy
Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported
-Patients filled out a form "Patient Evaluation of the Treated Breast". On this form the patients were asked to compare the memory of what their breast looked like after surgery but before radiation and to compare that memory to the appearance of the breast after radiation. The patients were then asked if their breast changes were due to: * caused mostly by radiation * caused by both the radiation and surgery, but mostly by the radiation * caused by both the radiation and surgery, but mostly by the surgery * caused mostly by the surgery * can't judge which treatment caused the change * there are no changes
Time frame: 3 years
Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA)
-Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA)
Time frame: Pre-treatment and 3 years
Presence or Absence of Complications
As defined by number of participants who experienced breast infection and symptomatic fat necrosis.
Time frame: 5 years after treatment completion
Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment
Time frame: 5 years after treatment completion
Frequency of Grade 3-4 Toxicities
RTOG acute and late toxicity grading system and via a visual analog scale for pain assessment.
Time frame: Up to 1 year from completion of therapy
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