Clinical Trials /

Excision Followed by Radiofrequency Ablation for Breast Cancer

NCT01153035

Description:

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.

Related Conditions:
  • Breast Invasive Ductal Carcinoma
  • Ductal Carcinoma In Situ
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Excision Followed by Radiofrequency Ablation for Breast Cancer
  • Official Title: ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 104603
  • NCT ID: NCT01153035
  • NCT ALIAS: NCT01420380

Conditions

  • Breast Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Surgery followed by RFAOther

    Eligibility Criteria

            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
          
    Maximum Eligible Age:100 Years
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Estimate the re-excision rate for close (<3mm) or positive margins
    Time Frame:Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)
    Safety Issue:
    Description:How many patients must go back for re-excision of margins

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Arkansas

    Trial Keywords

    • Breast Conservation Therapy
    • Lumpectomy
    • Radiofrequency Ablation
    • Radiation

    Last Updated

    January 29, 2018