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By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®, the current protocol attempts to mimic or improve the excellent local control rates seen in treatment of early stage breast cancer while attempting to increase convenience, limit invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Other | SBRT dose per fraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | 3 dose cohorts. Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 6 Gy per fraction for 5 fractions (total dose = 30 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum tolerated dose to the lumpectomy cavity in patients with early stage breast cancer | To escalate the dose of stereotactic radiotherapy utilizing the Cyberknife system to a tumorcidal dose to the lumpectomy cavity without exceeding the maximum tolerated dose in patients with early stage breast cancer. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | 3 years | |
| The cosmesis of breast | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asal Rahimi, MD | UT Southwestern Medical Center Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States | ||
| UT Southwestern Medical Center |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
|
| Dallas |
| Texas |
| 75390 |
| United States |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |