Intraoperative radiation therapy after breast surgery for older women with early stage breast cancer
Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
This study is testing whether giving radiation therapy right after breast surgery can help older women with early stage breast cancer avoid having their cancer come back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 168 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | Mount Carmel Health System Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT03536897 on ClinicalTrials.gov |
What this trial studies
This observational registry trial aims to enroll women aged 65 and older who have early stage, low risk breast cancer and will undergo partial mastectomy followed by intraoperative radiation therapy (IORT). The primary goal is to assess the 5-year risk of tumor recurrence in the breast, while secondary objectives include evaluating acute and late toxicity, cosmetic outcomes, disease-free survival, and overall survival rates. The study will provide valuable data on the effectiveness and safety of IORT in this patient population.
Who should consider this trial
Good fit: Ideal candidates are women aged 65 and older with early stage, low risk invasive ductal carcinoma who are suitable for breast conserving surgery.
Not a fit: Patients with multi-centric cancer, prior breast radiation, or those with certain genetic mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of tumor recurrence and improve overall treatment outcomes for older women with early stage breast cancer.
How similar studies have performed: Other studies have shown promising results with intraoperative radiation therapy, suggesting potential benefits for similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 hormonal or chemotherapy * Invasive lobular histology * Pure ductal carcinoma in situ (DCIS) * Grade 3 * Diffuse suspicious microcalcifications
Where this trial is running
Columbus, Ohio
- Mount Carmel West Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Malolan Rajagopalan, MD — Mount Carmel Health System
- Study coordinator: Lynn Shaffer, PhD
- Email: Lynn.Shaffer@mchs.com
- Phone: 614-234-3625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.