RAD 1802: Pilot Trial of LINAC Based Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)
RAD 1802: Pilot Trial of LINAC Based Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)
This study offers 5 fraction radiation treatment through partial breast irradiation in
 patients with early stage breast cancer after having a lumpectomy.
This study offers 5 fraction stereotactic body radiotherapy for early stage breast cancer
 after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility
 of delivering only 5 higher dose radiation treatments rather than the longer schedule of
 treatments that is currently considered standard of care for breast cancer patients. Patients
 will be followed for 24 months (2 years) with follow-up appointments at 6, 12, 18, and 24
 months.
Inclusion Criteria:

 -  Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or
 ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous
 (colloid) and tubular histologies are allowed.

 -  Age>50.

 -  Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS.

 -  Estrogen receptor (ER) positive (>10%).

 -  Must be eligible for breast conservation therapy and receive a lumpectomy with
 pathologic margins of at least 2mm.

 -  Must be clinically node negative by physical examination. Sentinel node dissection is
 not required, but if undertaken, the patient must be pathologically node negative.

 -  Zubrod Performance Status 0-2.

 Exclusion Criteria:

 -  Multifocal or multicentric cancer.

 -  Reception of neoadjuvant chemotherapy.

 -  Pure invasive lobular histology.

 -  Surgical margins<2mm.

 -  Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.

 -  Measured maximum PTV of >124cc.

 -  Lumpectomy cavity within 5mm of body contour.