Clinical Trials /

Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI

NCT02375048

Description:

Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI
  • Official Title: Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)

Clinical Trial IDs

  • ORG STUDY ID: 1288
  • NCT ID: NCT02375048

Conditions

  • Cancer of Breast

Purpose

Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.

Detailed Description

      Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB
      irradiation of the whole breast and surgical bed at two different dose levels. Dose
      prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with
      simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively.
      Daily image guided radiotherapy (IGRT) were generated before each treatment session in each
      patient to verify the set-up.

      Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated
      radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10
      days (every other day) with IGRT at each treatment.
    

Trial Arms

NameTypeDescriptionInterventions
Hypofractionated WBIActive ComparatorPatients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA).
    Accelerated Partial Breast IrradiationExperimentalPatients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).

      Eligibility Criteria

              Inclusion Criteria:
      
                -  55< Age <70
      
                -  Tumor size ≤ 2 cm
      
                -  pN0 (SN biopsy or ALND)
      
                -  ER/PgR positive
      
                -  Margins > 5 mm (either at initial surgery or at re-excision)
      
                -  Clips placed in the surgical bed (minimum of 4 clips)
      
                -  Unicentric only
      
                -  No lymphovascular invasion
      
                -  Any grade
      
                -  No extensive intraductal component (>25%)
      
                -  Written informed consent
      
              Exclusion Criteria:
      
                -  Prior thoracic radiation therapy
      
                -  Oncoplastic surgery / No clips in the surgical bed
      
                -  Multicentric cancer
      
                -  Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to
                   late sequelae
            
      Maximum Eligible Age:70 Years
      Minimum Eligible Age:55 Years
      Eligible Gender:Female
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Toxicity will be measured with CTCAE v.4.0
      Time Frame:ten years
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Rate of Local Control
      Time Frame:ten years
      Safety Issue:
      Description:
      Measure:Disease Free Survival
      Time Frame:ten years
      Safety Issue:
      Description:
      Measure:Overall Survival
      Time Frame:ten years
      Safety Issue:
      Description:
      Measure:Quality of Life Questionnaire
      Time Frame:ten years
      Safety Issue:
      Description:

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Istituto Clinico Humanitas

      Last Updated