Evaluation of Accelerated Partial Breast Brachytherapy
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
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Accelerated Partial Breast Brachytherapy as the Sole Method of Radiation Therapy for Stage 0, 1 and II Lymph Node Negative Breast Carcinoma|
- Proportion of patients who are free of breast cancer in the treated breast and regional lymph nodes after initial therapy. [ Time Frame: 5 years after treatment completion ] [ Designated as safety issue: No ]
- Quality of life as measured by EORTC, QLQ-C3, and QLQ-BR23. [ Time Frame: 5 years after treatment completion ] [ Designated as safety issue: No ]
- Cosmesis as measured by the BRA and pBRA. [ Time Frame: 5 years after treatment completion ] [ Designated as safety issue: No ]Baseline, 6-8 weeks after treatment, 4-6 month follow-up, 12 months follow-up, and at yearly intervals thereafter for 5 years
- Presence or absence of complications [ Time Frame: 5 years after treatment completion ] [ Designated as safety issue: Yes ]
- Occurrence of mastectomy after completion of initial breast-conserving treatment [ Time Frame: 5 years after treatment completion ] [ Designated as safety issue: No ]
- Frequency of grade 3-4 toxicities [ Time Frame: Up to 1 year from completion of therapy ] [ Designated as safety issue: Yes ]RTOF acute and late toxicity grading system and via a visual analog scale for pain assessment.
|Study Start Date:||December 2003|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Accelerated partial breast bracytherapy
Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.
brachytherapy (radioactive implants)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593346
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Imran Zoberi, MD||Washington University School of Medicine|