IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:65 - Any
Updated:5/27/2018
Start Date:February 27, 2018
End Date:February 27, 2028
Contact:Lynn Shaffer, PhD
Email:Lynn.Shaffer@mchs.com
Phone:614-234-3625

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Trial Summary
Trial Overview
Inclusion Criteria

Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

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.


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
We found this trial at
1
site
Mount Carmel West Hospital
Columbus, Ohio 43222
Phone: 614-234-5402
?
mi
from
Columbus, OH
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