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This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase II study. It will evaluate quality of life (QOL) issues as they relate to treatment related side effects, cosmetic result, and patient convenience.
Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CyberKnife Partial Breast Irradiation (PBI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyberKnife Partial Breast Irradiation | Radiation | Body radiosurgery will be delivered to the lumpectomy cavity with specified margin. Radiation dose will be 600 cGy x 5 stages = 3000 cGy over five to ten total days. |
| Measure | Description | Time Frame |
|---|---|---|
| 1. To evaluate the feasibility of CyberKnife body radiosurgery as the sole radiation therapy for this patient population 2. To evaluate the complication rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1. To evaluate the local control rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population. 2. To evaluate Quality of Life after CyberKnife body radiosurgery PBI. | 1 - 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jefferson EC Moulds, MD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgtown University Medical Center | Washington D.C. | District of Columbia | 20057 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |