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The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.
See points VIII inclusion/exclusion criteria
Operation:
After Surgery:
Follow-Up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Fraction IOeRT | Experimental | A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Fraction IOeRT | Radiation | A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who are free of breast cancer. | Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrance rate with acute toxicity and cosmetic evaluations | AEs and Lent Soma will be assessed for acute toxicity. We will use a 20% toxicity cutoff, the protocol would be stopped if 2/10 were determined to have developed significant toxicities, grade 3 or greater, at the first 6-month follow-up visit. 2/10 patients at 6-months follow-up, 4/20 patients at 1-year follow-up, 6/30 at 18-months follow-up, 8/40 at 24-months follow-up, 10/50 at 30-months follow-up, 12/60 at 36-months follow-up, 14/70 at 42-months follow-up, 16/80 at 48-months follow-up, 18/90 at 54-months and 20/100 at 60-months follow-up. Cosmetic evaluations will be completed by the patient and radiation oncologist an via breast exams, questionnaires and breast photo documentation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Arneson, MD | Avera Cancer Insitute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | 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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|
| 10 years |
| D017437 |
| Skin and Connective Tissue Diseases |