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Trial record 8 of 10 for:
klimberg and phase II
Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation (eRFA)
This study has been completed.
Sponsor:
University of Arkansas
Collaborator:
Angiodynamics, Inc.
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00571987
First received: December 11, 2007
Last updated: October 28, 2015
Last verified: October 2015
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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: | Intervention Model: Single Group Assignment Masking: None (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
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 ]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) ]
| 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) |
| Sexes 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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00571987
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:
Publications:
| 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 |
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 August 23, 2017