Breast Cancer Clinical Trial
— ABLATEOfficial title:
ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer
NCT number | NCT01153035 |
Other study ID # | 104603 |
Secondary ID | |
Status | Active, not recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2010 |
Est. completion date | June 2024 |
Verified date | January 2024 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 104 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas | Angiodynamics, Inc. |
United States,
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
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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