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| ID | Type | Description | Link |
|---|---|---|---|
| 000521633 | Other Grant/Funding Number | Varian Medical Systems |
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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.
This study offers 5 fractions 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 doses of radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 fractions stereotactic body radiation therapy at a dose of 6 gy for 5 fractions for treatment. Patients will be followed for 36 total months with specific follow-ups at 3, 6, 9, 12, 18, 24, and 36 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 Fraction Stereotactic Body Radiation Therapy | Radiation | Stereotactic body radiation therapy (SBRT) has gained favor in the treatment of select central nervous system, lung, and abdominal malignancies due to its ability to deliver highly conformal doses of radiotherapy while using sharp dose gradients to deliver comparatively lower doses to the surrounding normal tissue. Utilization of SBRT is more labor intensive than conventional fractionation and requires precise immobilization and localization techniques with daily image guidance with direct physician and physicist oversight for all treatments. While more labor intensive and often utilizing more advanced technologies, SBRT allows the advantage of reducing setup margins compared to conventionally fractionated treatment while being able to shorten overall treatment times due to the ability to safely dose escalate high risk areas |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0 | To determine the safety of 5 fractions 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. | 0-2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of breast SBRT using CTCAE v4.0 | To define the acute (<90 days) and late toxicity (>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy. | 0-2 years |
| Cosmetic outcome baseline and post-SBRT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| D. Hunter Boggs, MD | Contact | (205) 934-5670 | dhboggs@uabmc.edu | |
| D. Hunter Boggs, MD | Contact | (205) 975-5581 | dhboggs@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| D. Hunter Boggs, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC) | Recruiting | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35880164 | Derived | Liu Y, Veale C, Hablitz D, Krontiras H, Dalton A, Meyers K, Dobelbower M, Lancaster R, Bredel M, Parker C, Keene K, Thomas E, Boggs D. Feasibility and Short-Term Toxicity of a Consecutively Delivered Five Fraction Stereotactic Body Radiation Therapy Regimen in Early-Stage Breast Cancer Patients Receiving Partial Breast Irradiation. Front Oncol. 2022 Jul 8;12:901312. doi: 10.3389/fonc.2022.901312. eCollection 2022. |
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To determine patient and nurse assessed cosmetic outcome at baseline and 1, 6, 12, 18, 24, and 36 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.
| 0-2 years |
| Patient reported outcome baseline and post-SBRT | To determine patient reported outcome at baseline and 1, 6, 12, 18, 24, and 36 months post SBRT. The Quality of Life Breast Cancer Questionnaire (QLQ-BR45) is a 45-item questionnaire is composed of 45 questions with scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the QLQ-BR45 range from 45 to 180, with a lower score representing a higher quality of life. | 0-2 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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