Clinical Trials /

RAD 1802: Pilot Trial of LINAC Based Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

NCT03643861

Description:

This study offers 5 fraction radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

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

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT03643861

Trial Eligibility

Document

Title

  • Brief Title: RAD 1802: Pilot Trial of LINAC Based Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)
  • Official Title: RAD 1802: Pilot Trial of LINAC Based Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Clinical Trial IDs

  • ORG STUDY ID: IRB-300002157
  • NCT ID: NCT03643861

Conditions

  • Breast Cancer

Purpose

This study offers 5 fraction radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

Detailed Description

      This study offers 5 fraction stereotactic body radiotherapy for early stage breast cancer
      after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility
      of delivering only 5 higher dose radiation treatments rather than the longer schedule of
      treatments that is currently considered standard of care for breast cancer patients. Patients
      will be followed for 24 months (2 years) with follow-up appointments at 6, 12, 18, and 24
      months.

Trial Arms

NameTypeDescriptionInterventions
5 Fraction Breast Stereotactic Body Radiation TherapyExperimentalThis study will enroll patients that have a confirmed histology of early stage breast cancer. The patient will undergo a lumpectomy and will then receive partial breast 5 fraction stereotactic body radiation therapy at a dose of 30 gy for treatment. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.

    Eligibility Criteria

            Inclusion Criteria:

          -  Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or
             ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous
             (colloid) and tubular histologies are allowed.

          -  Age>50.

          -  Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS.

          -  Estrogen receptor (ER) positive (>10%).

          -  Must be eligible for breast conservation therapy and receive a lumpectomy with
             pathologic margins of at least 2mm.

          -  Must be clinically node negative by physical examination. Sentinel node dissection is
             not required, but if undertaken, the patient must be pathologically node negative.

          -  Zubrod Performance Status 0-2.

        Exclusion Criteria:

          -  Multifocal or multicentric cancer.

          -  Reception of neoadjuvant chemotherapy.

          -  Pure invasive lobular histology.

          -  Surgical margins<2mm.

          -  Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.

          -  Measured maximum PTV of >124cc.

          -  Lumpectomy cavity within 5mm of body contour.
    Maximum Eligible Age:99 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Toxicity levels of 5 fraction SBRT for partial breast irradiation assessed by CTCAE v4.0
    Time Frame:0-2 years
    Safety Issue:
    Description:To determine the safety of five fraction SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study.

    Secondary Outcome Measures

    Measure:Toxicity of breast SBRT using CTCAE v4.0
    Time Frame:0-2 years
    Safety Issue:
    Description:To define the acute (<90 days) and late toxicity (>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy.
    Measure:Cosmetic outcome post-SBRT
    Time Frame:0-2 years
    Safety Issue:
    Description:To determine patient and nurse assessed cosmetic outcome at 1, 6, 12, 18, and 24 months post SBRT. Patient will give a verbal satisfaction rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor of their cosmetic appearance post-SBRT. Nurse will also give their overall rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor based off of their examination of the cosmetic appearance post-SBRT.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Alabama at Birmingham

    Trial Keywords

    • SBRT
    • Breast cancer
    • Early stage
    • Radiation therapy

    Last Updated

    November 3, 2020