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This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.
For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IORT Arm | Experimental | Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Radiotherapy | Procedure | Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography. |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity Assessment | Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system:
| 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic Evaluation | Assessment of cosmetic outcome according to 5-point scoring system
| 5 years |
| Recurrence Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Wagman, M.D. | St. Joseph Hospital of Orange | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Hospital of Orange | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D018275 | Carcinoma, Lobular |
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Recurrence is assessed at month 6, 12, 24, 36, 48, 60
| 5 years |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |