RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)
RAD 1802: A Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)
University of Alabama at Birmingham
40 participants
Aug 20, 2019
INTERVENTIONAL
Conditions
Summary
This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.
Eligibility
Inclusion Criteria7
- 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 Criteria6
- Multifocal or multicentric cancer.
- Reception of neoadjuvant chemotherapy.
- Pure invasive lobular histology.
- Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
- Measured maximum PTV of \>124cc.
- Lumpectomy cavity within 5mm of body contour.
Interventions
Stereotactic body radiation therapy (SBRT) has gained favor in the treatment of select central nervous system, lung, and abdominal malignancies due to its ability to deliver highly conformal doses of radiotherapy while using sharp dose gradients to deliver comparatively lower doses to the surrounding normal tissue. Utilization of SBRT is more labor intensive than conventional fractionation and requires precise immobilization and localization techniques with daily image guidance with direct physician and physicist oversight for all treatments. While more labor intensive and often utilizing more advanced technologies, SBRT allows the advantage of reducing setup margins compared to conventionally fractionated treatment while being able to shorten overall treatment times due to the ability to safely dose escalate high risk areas
Locations(1)
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NCT03643861