Excision Followed by Radiofrequency Ablation for Breast Cancer

N/AActive Not RecruitingNCT01153035

University of Arkansas104 enrolled

Overview

The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Breast Cancer

Interventions

Radiofrequency AblationDEVICE

Breast conservation surgery followed by Radiofrequency Ablation of the cavity

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is a female, ≥ 50 years of age * The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam) * The tumor is unicentric and unilateral * The tumor is not involving the skin * Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III * If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+) * Patient signs current written informed consent and HIPAA forms Exclusion Criteria: * Patient is under 50 years of age * Patient is male * Tumor \> 3 cm in diameter * Bilateral malignancy * Clinically positive lymph nodes * Tumor involving the skin * Pathology confirms invasive lobular carcinoma * Breast implants * Less than 2 years disease-free survival from previous breast cancer * Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years

Locations (6)

University of Arizona

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Sharp Oncology (Comprehensive Breast Care of San Diego)

San Diego, California, United States

Comprehensive Breast Care of Denver

Denver, Colorado, United States

Outcomes

Primary Outcomes

Estimate the re-excision rate for close (<3mm) or positive margins

How many patients must go back for re-excision of margins

Time frame: Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)

Decrease local recurrence

The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences.

Time frame: Monitor throughout 5 year follow-up

Data from ClinicalTrials.gov

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