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

Purpose

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.

Condition	Intervention	Phase
Cancer of the Breast	Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Number of Patients Requiring 2nd Surgery for Close or Positive Margins [ Time Frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Recurrence of Breast Cancer at Prior Site of Disease [ Time Frame: Until study end (2 years) ] [ Designated as safety issue: No ]


Enrollment:	107
Study Start Date:	September 2004
Study Completion Date:	December 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).	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.

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571987

Locations


United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Angiodynamics, Inc.

Investigators


Principal Investigator:	V. Suzanne Klimberg, M.D.	University of Arkansas

More Information

Additional Information:

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.


Responsible Party:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00571987 History of Changes
Other Study ID Numbers:	UAMS 29143
Study First Received:	December 11, 2007
Results First Received:	July 29, 2015
Last Updated:	October 28, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:


Breast cancer Lumpectomy Radiofrequency Ablation Negative margins Breast Conserving Surgery

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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