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Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

ConditionsDuctal Carcinoma in SituInvasive Ductal Carcinoma of Female Breast
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

This trial accepts healthy volunteers

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 population

SBRT for treatment of the surgical cavity following partial mastectomy for women with early-stage breast cancer will be studied.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • stereotactic body radiation therapy

    Radiation

    Treatment technique used to deliver a highly focused and accurate radiation dose to a defined target volume outside the brain; the entire course of therapy delivered in five fractions or less

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS)

physician and patient assessment of breast cosmetic result following SBRT

Time frame
2-3 years
2

Acute breast toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

assessment of skin and breast tissue changes during and immediately following SBRT

Time frame
1-6 weeks
3

Other late toxicities as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

assessment of pulmonary, cardiac and chest wall changes following SBRT

Time frame
3-60 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RPCR, Inc.

Lead sponsor

CyberKnife Coalition

Collaborator

Source ClinicalTrials.gov
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