Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2011 |
| End Date: | December 2021 |
The purpose of this research study is to find out the effects (good and bad) of adding a
dose of radiation to the area of the cancer during surgery to whole breast radiation therapy
(WBRT) after surgery. IOERT is the application of electron radiation directly to the
residual tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used
to treat patients who have cancer in the breast covering the entire breast tissue. Both
immediate and long-term effects will be measured.
For patients with certain types of breast cancer, one standard treatment is removal of the
area of cancer 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 of WBRT followed by
5-8 daily radiation treatments at the site where the lump was removed called a "boost".
During this study, the single dose of electron irradiation (IOERT) given at the surgical
site during the operation will replace the usual 5-8 days of localized radiation and the
whole breast radiation will last 3 weeks.
dose of radiation to the area of the cancer during surgery to whole breast radiation therapy
(WBRT) after surgery. IOERT is the application of electron radiation directly to the
residual tumor or tumor bed during cancer surgery. WBRT is a type of radiation therapy used
to treat patients who have cancer in the breast covering the entire breast tissue. Both
immediate and long-term effects will be measured.
For patients with certain types of breast cancer, one standard treatment is removal of the
area of cancer 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 of WBRT followed by
5-8 daily radiation treatments at the site where the lump was removed called a "boost".
During this study, the single dose of electron irradiation (IOERT) given at the surgical
site during the operation will replace the usual 5-8 days of localized radiation and the
whole breast radiation will last 3 weeks.
Inclusion Criteria:
- Histological proven invasive breast carcinoma (ductal and lobular)
- Age > 40 years
- Karnofsky performance status >70%
- Single discrete tumor or focal microcalcifications that can be imaged on a specimen
radiograph or multifocal disease within the same quadrant with a maximum dimension of
4 cm (invasive foci)
- Nodal Status: NO-1
- Clear surgical margins: R0; min 2mm. Re-excision after IOERT is permitted but not
required to achieve (-) margin.
- All grades G1 - G3
- Any hormonal receptor and Her-2 status
- Informed consent
Exclusion Criteria:
- In-situ Carcinoma without invasive component or multifocal disease > 4 cm
- Tumor stage: T3 or 4
- Nodal Status > N1 pathologically
- Surgical margins < 2mm
- Multicentricity
- Previous radiotherapy to the involved breast
- Karnofsky Index < 70%
- Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis
obliterans, systemic lupus.
- Distant metastases
- Unable to provide written consent
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