This trial studies the side effects of accelerator based stereotactic body radiation therapy and to see how well it works after surgery in treating patients with early stage breast cancer. Whole breast radiation therapy is the standard of care after lumpectomy surgery. However, in women with very favorable tumors, accelerated partial breast irradiation (APBI) is safe and effective. The technique for APBI used in this trial is called stereotactic body radiation therapy (SBRT). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue compared to other APBI techniques.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03643861.
Locations matching your search criteria
United States
Alabama
Birmingham
University of Alabama at Birmingham Cancer CenterStatus: Active
Contact: Drexell Hunter Boggs
Phone: 205-996-0780
PRIMARY OBJECTIVES:
I. To determine the safety and feasibility of 5 fraction stereotactic body radiation therapy (SBRT) for partial breast irradiation in patients with early stage breast cancer after lumpectomy.
SECONDARY OBJECTIVES:
I. To define the acute (=< 90 days) and late toxicity (> 90 days) up to three years after breast SBRT (Common Terminology Criteria for Adverse Events [CTCAE] 4) attributable to therapy.
II. To determine patient and nurse assessed cosmetic outcome at 1, 6, 12, 18, 24 and 36 months post SBRT.
III. To assess local control, recurrence free survival, disease-specific survival and ipsilateral breast tumor recurrence rates at 6, 12, 18, 24 and 36 months post SBRT.
OUTLINE:
Patients undergo lumpectomy and then after 8 weeks undergo accelerator based SBRT over 25-30 minutes daily for 5 days.
After completion of study treatment, patients are followed up at 1, 6, 12, 18, 24, and 36 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorDrexell Hunter Boggs
