Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

Phase 2CompletedNCT00571987

University of Arkansas107 enrolled

Overview

In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.

While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (\< 3 mm) which occurs on average in \~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Cancer of the Breast

Interventions

AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)DEVICE

Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female, 18-100 years old * Not pregnant or breastfeeding * Pre-study radiologic documentation of: * size ≤ 5 cm * unicentric, unilateral * suspicious mass or calcification * BIRADS classification ≥ IV * location of abnormality \> 1 cm from skin * Ductal or Infiltrating Ductal Carcinoma * Grade I-III on final pathology * Good general health * Zubrod Performance Status of 0,1, or 2 * No previous chemotherapy * No palpable axillary or supraclavicular lymph nodes * If prior non-breast malignancy, must have \> 5 year disease-free survival Exclusion Criteria: * Patient \< 18 y/o or \> 100 y/o * Pregnant or breastfeeding * Male * Breast implants * Multicentric disease or bilateral disease * Lesions \> 5 cm in diameter * Lesions \< 1.0 cm from the skin * Previous prior radiation to the breast * Need for mastectomy * Diffuse microcalcifications (as determined by the Investigator)

Locations (1)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Number of Patients Requiring 2nd Surgery for Close or Positive Margins

A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.

Time frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery

Secondary Outcomes

Recurrence of Breast Cancer at Prior Site of Disease

Time frame: Until study end (2 years)

Data from ClinicalTrials.gov

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