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)
Recruiting · NCT03643861 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
5 Fraction Stereotactic Body Radiation Therapy
What this trial is about
This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
- Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
- Measured maximum PTV of \>124cc.
- Lumpectomy cavity within 5mm of body contour.
Where it is running
1 location listed across 1 US state.
- University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC) - Birmingham, Alabama, United States