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

Cancer of the Breast Clinical Trial

— eRFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571987
• Other study ID #: UAMS 29143
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 11, 2007
• Last updated: October 28, 2015
• Start date: September 2004
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer of the Breast

Intervention

Device:
• AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)
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.

Locations

Country	Name	City	State
United States	University of Arkansas For Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Angiodynamics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Klimberg VS, Boneti C, Adkins LL, Smith M, Siegel E, Zharov V, Ferguson S, Henry-Tillman R, Badgwell B, Korourian S. Feasibility of percutaneous excision followed by ablation for local control in breast cancer. Ann Surg Oncol. 2011 Oct;18(11):3079-87. doi: 10.1245/s10434-011-2002-y. Epub 2011 Sep 9. — View Citation

Klimberg VS, Kepple J, Shafirstein G, Adkins L, Henry-Tillman R, Youssef E, Brito J, Talley L, Korourian S. eRFA: excision followed by RFA-a new technique to improve local control in breast cancer. Ann Surg Oncol. 2006 Nov;13(11):1422-33. Epub 2006 Sep 29. — View Citation

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):2618-9. doi: 10.1245/s10434-012-2293-7. Epub 2012 Mar 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Margins assessed at Final Pathology, approximately 1 week post-RF surgery	No
Secondary	Recurrence of Breast Cancer at Prior Site of Disease		Until study end (2 years)	No

External Links

•   Long-Term Results of Phase II Ablation after Breast Lumpectomy Added to Extend Intraoperative Margins (ABLATE l) Trial Presented at the Southern Surgical Association 125th Annual Meeting, Hot Springs, VA, December 2013.