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)

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC)
RECRUITING
Birmingham
Contact Information
Primary
D. Hunter Boggs, MD
dhboggs@uabmc.edu
(205) 934-5670
Backup
D. Hunter Boggs, MD
dhboggs@uabmc.edu
(205) 975-5581
Time Frame
Start Date: 2019-08-20
Estimated Completion Date: 2028-12
Participants
Target number of participants: 40
Treatments
Experimental: 5 Fraction Breast Stereotactic Body Radiation Therapy
This study will enroll patients that have a confirmed histology of early stage breast cancer. The patient will undergo a lumpectomy and will then receive partial breast 5 fractions stereotactic body radiation therapy at a dose of 6 gy for 5 fractions for treatment. Patients will be followed for 36 total months with specific follow-ups at 3, 6, 9, 12, 18, 24, and 36 months.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: Varian Medical Systems

This content was sourced from clinicaltrials.gov