Description:
This study offers 5 fraction radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.
This study offers 5 fraction radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.
Recruiting
N/A
This study offers 5 fraction stereotactic body radiotherapy for early stage breast cancer after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility of delivering only 5 higher dose radiation treatments rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 24 months (2 years) with follow-up appointments at 6, 12, 18, and 24 months.
Name | Type | Description | Interventions |
---|---|---|---|
5 Fraction Breast Stereotactic Body Radiation Therapy | Experimental | This study will enroll patients that have a confirmed histology of early stage breast cancer. The patient will undergo a lumpectomy and will then receive partial breast 5 fraction stereotactic body radiation therapy at a dose of 30 gy for treatment. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months. |
Inclusion Criteria: - Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed. - Age>50. - Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS. - Estrogen receptor (ER) positive (>10%). - Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm. - Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative. - Zubrod Performance Status 0-2. Exclusion Criteria: - Multifocal or multicentric cancer. - Reception of neoadjuvant chemotherapy. - Pure invasive lobular histology. - Surgical margins<2mm. - Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan. - Measured maximum PTV of >124cc. - Lumpectomy cavity within 5mm of body contour.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Toxicity levels of 5 fraction SBRT for partial breast irradiation assessed by CTCAE v4.0 |
Time Frame: | 0-2 years |
Safety Issue: | |
Description: | To determine the safety of five fraction SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study. |
Measure: | Toxicity of breast SBRT using CTCAE v4.0 |
Time Frame: | 0-2 years |
Safety Issue: | |
Description: | To define the acute (<90 days) and late toxicity (>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy. |
Measure: | Cosmetic outcome post-SBRT |
Time Frame: | 0-2 years |
Safety Issue: | |
Description: | To determine patient and nurse assessed cosmetic outcome at 1, 6, 12, 18, and 24 months post SBRT. Patient will give a verbal satisfaction rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor of their cosmetic appearance post-SBRT. Nurse will also give their overall rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor based off of their examination of the cosmetic appearance post-SBRT. |
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Alabama at Birmingham |
November 3, 2020