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

Recruitingn/aAges 50 Years - 100 YearsFemaleRPCR, Inc.
NCT04985032 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Women 50 years or older 2. Low to intermediate grade DCIS or invasive ductal carcinoma 3. Tumor size \< 2 cm invasive ductal carcinoma and \< 2.5 cm DCIS 4. Well defined lumpectomy cavity on CT 5. Clear surgical ink margins \> 2mm for invasive cancer and \> 3 mm for DCIS 6. Node negative 7. Unifocal lesion 8. ER and/or PR positive 9. HER-2 negative 10. BRCA negative 11. Lumpectomy cavity must be \< 30% of whole breast volume Exclusion Criteria: 1. Lobular histology 2. Angiolymphatic invasion 3. Multiple foci of disease 4. Lymphovascular invasion 5. Active lupus or sarcoid 6. Distant metastases 7. Non-epithelial malignancies 8. Synchronous contralateral breast cancer 9. Grade 2 or higher oncoplastic surgery 10. Ipsilateral pacemaker 11. Ipsilateral breast implant 12. Neoadjuvant chemotherapy 13. Prior ipsilateral breast cancer or thoracic radiation 14. Poor breast integrity 15. Paget's Disease of the nipple 16. Pregnant patients 17. Severe cardiac, pulmonary, or liver diseases
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What it tests

  • stereotactic body radiation therapy
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Where

2 sites
CyberKnife Center of South Florida in Stuart
Stuart, United States
CyberKnife Centers of Tampa Bay
Tampa, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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