Clinical Trials /

Intraoperative Radiotherapy After Local Recurrence in Breast Cancer

NCT02386371

Description:

The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Intraoperative Radiotherapy After Local Recurrence in Breast Cancer
  • Official Title: Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: ICM-URC2014/07
  • NCT ID: NCT02386371

Conditions

  • Breast Carcinoma

Purpose

The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

Detailed Description

      Currently, the rate of ipsilateral breast tumor recurrence (IBTR) after breast- conserving
      surgery and radiotherapy remains at 10% at 10 years to 15% at 20 years, respectively. IBTR is
      an independent predictor of poor survival with a 3 to 4.6 increased risk of cancer-related
      death.

      In a heterogeneous population, local control remains a major therapeutic challenge for these
      relapses, especially those considered of better prognosis, namely occurring late and of low
      histological grade. Therapeutic de-escalation is possible for these relapses to avoid a
      mutilating and often traumatic mastectomy.

      However, this second conservative surgery has a high rate of second local relapse (19 to 50%
      at 5 years) due to the absence of a re-irradiation, rendered impossible by the problem of
      tolerance of previously irradiated tissues.

      Retrospective or prospective studies on partial breast irradiation (PBI) in adjuvant setting
      report promising results, both in terms of tolerance (saving healthy tissue) and local
      control (74% to 100% at 5 years). Used techniques include brachytherapy, external beam
      radiotherapy and intraoperative radiotherapy (IORT).

      IORT is now the subject of renewed interest in breast cancer. It has the advantages of
      high-precision ballistics on the operated area and of preservation of healthy tissue. To
      date, no prospective data, however, have been published in the indication of ipsilateral
      breast recurrence.

      A prospective, multicenter, single arm Phase II design will evaluate the feasibility of
      repeated breast-conserving surgery combined with re- irradiation using IORT after local
      recurrence of breast carcinoma.
    

Trial Arms

NameTypeDescriptionInterventions
surgery and Intra Operative RadiotherapyExperimentalSurgery : Tumorectomy will be performed according to the current standards, obtaining "clear" margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams. Intra Operative Radiotherapy (IORT): After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically proven non-lobular invasive breast recurrence
    
              -  Time from whole breast radiation following the initial lumpectomy >5 years
    
              -  Unifocal tumor
    
              -  Recurrent tumor size ≤ 2 cm
    
              -  Adequate breast size for a second breast-conserving surgery with acceptable cosmetic
                 result
    
              -  Bilateral breast mammogram within 90 days prior to study entry
    
              -  Breast MRI within 90 days prior to study entry
    
              -  Histological grade I-II
    
              -  Estrogen-receptor-positive tumor (ER+)
    
              -  Cerb2-negative tumor
    
              -  N0
    
              -  M0
    
              -  Prior radiotherapy delivered within a standard fractionation schedule
    
              -  Performance status (ECOG) 0-1
    
              -  Women ≥ 50 years -Absence of any psychological, familial, sociological, or
                 geographical conditions with a potential to hamper compliance with the study and
                 follow- up schedule
    
              -  Affiliated to the French Health Insurance regimen
    
              -  Written and signed informed consent form.
    
            Exclusion Criteria:
    
              -  Multifocal and/or multicenter recurrence
    
              -  Lobular carcinoma
    
              -  Estrogen-receptor-negative tumor (ER-)
    
              -  Cerb2 (her2) overexpressed - breast cancer
    
              -  Extensive intraductal component (EIC) on biopsy
    
              -  Lymph vessel invasion on biopsy
    
              -  N1-3 status: Regional cytological or histologically proven node recurrence
    
              -  M1 status: Metastatic disease
    
              -  cT4 (Skin or muscle involvement) or Paget's disease of the nipple
    
              -  Prior radiotherapy delivered within an accelerated or hypo-fraction schedule
    
              -  Prior malignancy other than non-melanoma skin cancer unless the patient has been
                 disease free for at least 5 years
    
              -  Patients with a small breast volume, technically unsatisfactory for a second
                 conservative surgery or intraoperative breast irradiation.
    
              -  Preoperative chemotherapy or hormone therapy for local relapse
    
              -  Connective tissue disease or scleroderma, contraindicating radiotherapy
    
              -  Known BRCA1/2 gene mutation (genetic testing is not required)
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Tolerance of intra operative radiation as assessed by acute and late toxicities
    Time Frame:up to 5 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Cosmetic outcome evaluated by photography
    Time Frame:up to 5 years
    Safety Issue:
    Description:To

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Institut du Cancer de Montpellier - Val d'Aurelle

    Last Updated

    August 16, 2017