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| ID | Type | Description | Link |
|---|---|---|---|
| GCC 0919 |
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The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy is performed. By administering the PBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The PBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an x-ray beam to deliver the radiation dose. Approximately 3 weeks after completion of the PBI, the cancer will be surgically removed.
This study will learn about the good and bad effects of 3D-conformal external beam irradiation PBI when given before the cancer has been removed by lumpectomy. The study will also learn about the feelings women have about how their breast looks after PBI and surgery.
This study will evaluate the feasibility, cosmetic results, complication rates, and local control rate of 3D-CRT confined to the region of the lumpectomy cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. For selected patients with Stage I and II breast carcinoma, 3D-CRT delivered to the primary tumor preoperatively is technically reproducible with acceptable complication rates. Cosmetic results after partial breast irradiation before lumpectomy will be comparable to that obtained after whole breast external beam radiation therapy. The local tumor control rate in the breast after partial breast irradiation therapy followed by lumpectomy will be comparable to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Phase II-Preoperative Radiation followed by Lumpectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase II - Preoperative Radiation followed by Lumpectomy. | Other | Sequential investigative question. All procedures are standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of this study is determination of the reproducibility of delivering preoperative APBI in Stage I and Stage IIA breast cancers. | This will be done by using 3D-CRT by evaluating the prescription isodose curves, dose inhomogeneity, and coverage of the volume as defined by CT treatment planning to delineate the target volume. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pathologic response, cosmetic results, of lumpectomy wound healing and the overall complication rate, ipsilateral breast recurrence rate | These endpoints will be accomplished by utilizing the pathology report; the cosmesis will be judged by the patient, radiation oncologist and/or surgeon, at stated follow-up intervals; and the breast recurrence rate will be evaluated by disease status at routine patient follow-up appointments, including yearly mammography. |
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Inclusion Criteria:
Women who satisfy all of the following conditions are the only patients who will be eligible for this study:
Exclusion Criteria:
Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study:
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| Name | Affiliation | Role |
|---|---|---|
| Wendla Citron, MD | UMMC MSGCC Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ummc Msgcc | Baltimore | Maryland | 21201 | United States | ||
| Central Maryland Oncology Center |
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| 5 years |
| Columbia |
| Maryland |
| 21044 |
| United States |
| Baltimore Washington Medical Center | Glen Burnie | Maryland | 21061 | United States |
| 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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