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)

NCT03643861 | Recruiting FDA Device

• 2 other identifiers: IRB-300002157000521633
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

SBRT; Breast cancer; Early stage; Radiation therapy

Outcome Measures

Primary Outcomes (1)

• Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0

  To determine the safety of 5 fractions SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study.

  0-2 years

Secondary Outcomes (3)

• Toxicity of breast SBRT using CTCAE v4.0

  0-2 years

• Cosmetic outcome baseline and post-SBRT

  0-2 years

• Patient reported outcome baseline and post-SBRT

  0-2 years

Study Arms (1)

5 Fraction Breast Stereotactic Body Radiation Therapy

EXPERIMENTAL

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

Interventions

5 Fraction Stereotactic Body Radiation Therapy RADIATION

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

5 Fraction Breast Stereotactic Body Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Varian Medical Systems: collaborator

Study Sites (1)

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

Birmingham, Alabama, 35233, United States

RECRUITING

Related Publications (1)

• Liu Y, Veale C, Hablitz D, Krontiras H, Dalton A, Meyers K, Dobelbower M, Lancaster R, Bredel M, Parker C, Keene K, Thomas E, Boggs D. Feasibility and Short-Term Toxicity of a Consecutively Delivered Five Fraction Stereotactic Body Radiation Therapy Regimen in Early-Stage Breast Cancer Patients Receiving Partial Breast Irradiation. Front Oncol. 2022 Jul 8;12:901312. doi: 10.3389/fonc.2022.901312. eCollection 2022.

  PMID: 35880164 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• D. Hunter Boggs, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

D. Hunter Boggs, MD

CONTACT

(205) 934-5670; dhboggs@uabmc.edu

D. Hunter Boggs, MD

CONTACT

(205) 975-5581; dhboggs@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 23, 2018
• Study Start: August 20, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)