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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01153035
Other study ID # 104603
Secondary ID
Status Recruiting
Phase N/A
First received June 24, 2010
Last updated August 30, 2017
Start date June 2010
Est. completion date June 2020

Study information

Verified date August 2017
Source University of Arkansas
Contact Beth Scanlan
Phone 5015266245
Email bscanlan@uams.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Other known NCT identifiers
  • NCT01420380

Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 2020
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Radiofrequency Ablation
Breast conservation surgery followed by Radiofrequency Ablation of the cavity

Locations

Country Name City State
United States Comprehensive Breast Care of Denver Denver Colorado
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Columbia New York New York
United States Sharp Oncology (Comprehensive Breast Care of San Diego) San Diego California
United States University of Arizona Tucson Arizona
United States The University of Kansas Cancer Center Westwood Kansas

Sponsors (2)

Lead Sponsor Collaborator
University of Arkansas Angiodynamics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Klimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I, Korourian S. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014 Apr;218(4):741-9. doi: 10.1016/j.jamcollsurg.2013.12.032. Epub 2014 Jan 11. — View Citation

Mackey A, Feldman S, Vaz A, Durrant L, Seaton C, Klimberg VS. Radiofrequency ablation after breast lumpectomy added to extend intraoperative margins in the treatment of breast cancer (ABLATE): a single-institution experience. Ann Surg Oncol. 2012 Aug;19(8 — View Citation

Wilson M, Korourian S, Boneti C, Adkins L, Badgwell B, Lee J, Suzanne Klimberg V. Long-term results of excision followed by radiofrequency ablation as the sole means of local therapy for breast cancer. Ann Surg Oncol. 2012 Oct;19(10):3192-8. doi: 10.1245/ — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Estimate the re-excision rate for close (<3mm) or positive margins How many patients must go back for re-excision of margins Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)
Primary 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. Monitor throughout 5 year follow-up
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