NCT03643861 · University of Alabama at Birmingham
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)
What this study 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.
View original scientific description
This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.
Interventions
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
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
Where
- Birmingham, Alabama
Collaborators
Varian Medical Systems
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 31, 2025 · Source of record for eligibility and locations