NCT04985032 · RPCR, Inc.
Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)
What this study is about
This is a multi-institutional, forward-looking, observational registry investigating the safety and effectiveness 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.
View original scientific description
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.
Interventions
RADIATION
stereotactic body radiation therapy
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
Primary outcome measures
Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS)
Time frame: 2-3 years
physician and patient assessment of breast cosmetic result following SBRT
Acute breast toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: 1-6 weeks
assessment of skin and breast tissue changes during and immediately following SBRT
Other late toxicities as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: 3-60 months
assessment of pulmonary, cardiac and chest wall changes following SBRT
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
- 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
- Clear surgical ink margins \> 2mm for invasive cancer and \> 3 mm for DCIS
- Node negative
- Unifocal lesion
- ER and/or PR positive
- HER-2 negative
- BRCA negative
- Lumpectomy cavity must be \< 30% of whole breast volume
Exclusion criteria
- Lobular histology
- Angiolymphatic invasion
- Multiple foci of disease
- Lymphovascular invasion
- Active lupus or sarcoid
- Distant metastases
- Non-epithelial malignancies
- Synchronous contralateral breast cancer
- Grade 2 or higher oncoplastic surgery
- Ipsilateral pacemaker
- Ipsilateral breast implant
- Neoadjuvant chemotherapy
- Prior ipsilateral breast cancer or thoracic radiation
- Poor breast integrity
- Paget's Disease of the nipple
- Pregnant patients
- Severe cardiac, pulmonary, or liver diseases
Where
- Stuart, Florida
- Tampa, Florida
Collaborators
CyberKnife Coalition
Related conditions & keywords
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 Aug 5, 2022 · Source of record for eligibility and locations