Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age50-100
SponsorRPCR, Inc.
About this trial
This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years
Eligibility criteria
Qualifiers
Women 50 years or older
Low to intermediate grade DCIS or invasive ductal carcinoma
Tumor size < 2 cm invasive ductal carcinoma and < 2.5 cm DCIS
Well defined lumpectomy cavity on CT
Disqualifiers
Lobular histology
Angiolymphatic invasion
Multiple foci of disease
Lymphovascular invasion
Trial design
Treatments tested in this trial
- stereotactic body radiation therapy
Treatment groups
No treatment groups listed
Sponsors and collaborators
RPCR, Inc.
Lead sponsor
CyberKnife Coalition
Collaborator
Source ClinicalTrials.gov