Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
Mount Carmel Health System
Summary
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.
Eligibility
- Age range
- 65+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female * ECOG performance status 0-1 * Age 65 years or older * cT1 or cT2 (≤3.0 cm) * Invasive ductal carcinoma histology * Estrogen receptor positive (ER+) * Grade 1 or Grade 2 * Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling * Suitable for breast conserving surgery and radiation therapy * Patient must be able to provide study-specific informed consent Exclusion Criteria: * Multi-centric cancer not amenable to single lumpectomy * Prior ipsilateral whole breast radiation * Known BRCA 1 or BRCA 2 mutation * Status post neoadjuvant ho…
Interventions
- RadiationIORT
Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy
Location
- Mount Carmel West HospitalColumbus, Ohio