Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
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)

Led by University of Alabama at Birmingham · Updated on 2025-10-31

40

Participants Needed

1

Research Sites

484 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

V

Varian Medical Systems

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically proven invasive mammary carcinoma, invasive ductal carcinoma (IDC), or ductal carcinoma in situ (DCIS) of the breast, including medullary, papillary, mucinous (colloid), and tubular histologies
  • Age over 50 years
  • Maximum tumor size less than 2.0 cm if invasive carcinoma or less than 2.5 cm if pure DCIS
  • Estrogen receptor (ER) positive with more than 10% expression
  • Eligible for breast conservation therapy and have received a lumpectomy with pathologic margins of at least 2 mm
  • Clinically node negative by physical examination; sentinel node dissection not required but if done, must be pathologically node negative
  • Zubrod Performance Status of 0 to 2
Not Eligible

You will not qualify if you...

  • Multifocal or multicentric cancer
  • Previous neoadjuvant chemotherapy
  • Pure invasive lobular histology
  • Inability to clearly see the lumpectomy cavity on post-lumpectomy planning scan
  • Planning target volume (PTV) greater than 124 cc
  • Lumpectomy cavity located within 5 mm of the body contour

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Birmingham, Alabama, United States, 35233

Actively Recruiting

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Research Team

D

D. Hunter Boggs, MD

CONTACT

D

D. Hunter Boggs, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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