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NCT Number: NCT03643861

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)

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

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Birmingham, Alabama, 35233, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 0-2 years

    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.

Secondary outcomes

  1. Toxicity of breast SBRT using CTCAE v4.0

    Time frame: 0-2 years

    To define the acute (<90 days) and late toxicity (>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy.

  2. Cosmetic outcome baseline and post-SBRT

    Time frame: 0-2 years

    To determine patient and nurse assessed cosmetic outcome at baseline and 1, 6, 12, 18, 24, and 36 months post SBRT. Patient will give a verbal satisfaction rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor of their cosmetic appearance post-SBRT. Nurse will also give their overall rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor based off of their examination of the cosmetic appearance post-SBRT.

  3. Patient reported outcome baseline and post-SBRT

    Time frame: 0-2 years

    To determine patient reported outcome at baseline and 1, 6, 12, 18, 24, and 36 months post SBRT. The Quality of Life Breast Cancer Questionnaire (QLQ-BR45) is a 45-item questionnaire is composed of 45 questions with scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the QLQ-BR45 range from 45 to 180, with a lower score representing a higher quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

D. Hunter Boggs, MD

CONTACT

[email protected]

(205) 934-5670

D. Hunter Boggs, MD

CONTACT

[email protected]

(205) 975-5581

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Varian Medical Systems

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Aug 23, 2018
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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