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)

NCT ID: NCT03643861

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2028-12-31

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

5 Fraction Stereotactic Body Radiation Therapy

Intervention Type: 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

Interventions

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

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Drexell Hunter Boggs

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

D. Hunter Boggs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

D. Hunter Boggs, MD

Role: CONTACT

dhboggs@uabmc.edu

(205) 934-5670

D. Hunter Boggs, MD

Role: CONTACT

dhboggs@uabmc.edu

(205) 975-5581

References

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.

Reference Type: DERIVED

PMID: 35880164 (View on PubMed)

Other Identifiers

000521633

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300002157

Identifier Type: -

Identifier Source: org_study_id