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)

Purpose

This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

Condition

  • Breast Cancer

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Radiation: 5 Fraction Stereotactic Body Radiation Therapy
    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

Recruiting Locations

University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC)
Birmingham, Alabama 35233

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

D. Hunter Boggs, MD
(205) 934-5670
dhboggs@uabmc.edu

Detailed Description

This study offers 5 fractions 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 doses of radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.