IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Mount Carmel Health System168 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

168

Conditions

Breast Cancer

Interventions

IORTRADIATION

Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

Eligibility

Sex: FEMALEMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Mount Carmel West Hospital

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

In-Breast Tumor Recurrence (IBTR)

Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.

Time frame: 5 years

Secondary Outcomes

Late Toxicity

Degree of late radiation toxicity will be scored based upon RTOG/EORTC (Radiation Therapy Oncology Group/Eastern Oncology Radiation Therapy Consortium) late radiation morbidity scoring schema for subcutaneous tissue as well as cosmetic result. The RTOG/EORTC late radiation morbidity scoring schema on subcutaneous tissue is as follows: * GRADE 1: Slight induration (fibrosis) and loss of subcutaneous fat * GRADE 2: Moderate fibrosis but asymptomatic; slight field contracture; \<10% linear reduction * GRADE 3: Severe induration and loss of subcutaneous tissue; field contracture \> 10% linear measurement * GRADE 4: Necrosis

Time frame: 5 years

Acute Toxicity

Acute radiation toxicity will be scored at the first follow-up visit after IORT (4-6 weeks after treatment). Radiation dermatitis will be scored based upon CTCAE (Common Terminology Criteria for Adverse Events) v4.03 scale as follows: * GRADE 1: Faint erythema or dry desquamation * GRADE 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema * GRADE 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion * GRADE 4: Life threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated Other acute toxicity will also be scored per the CTCAE v4.03 scale and will be rated on the relation to radiation therapy (definitely related, probably related, possibly related, unlikely related, unrelated)

Time frame: 3 months

Disease Free Survival

Time frame: 5 yeras

Central Contacts

Lynn Shaffer, PhD

CONTACT

614-234-3625 Lynn.Shaffer@mchs.com

Data from ClinicalTrials.gov

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