Clinical Trials /

Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

NCT02297672

Description:

Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well tolerated form of partial breast radiotherapy. This protocol aims to build on the initial experience and to further refine the technique and collect toxicity and cost data, especially in comparison to alternate forms of breast radiotherapy.

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

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
  • Official Title: Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant

Clinical Trial IDs

  • ORG STUDY ID: H14-02175
  • NCT ID: NCT02297672

Conditions

  • Early Stage Breast Cancer

Purpose

Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well tolerated form of partial breast radiotherapy. This protocol aims to build on the initial experience and to further refine the technique and collect toxicity and cost data, especially in comparison to alternate forms of breast radiotherapy.

Detailed Description

      25 women with low stage (pT1pN0) breast cancer, grade 1 or 2, will be accrued for adjuvant
      partial breast radiotherapy using PBSI and prospectively followed for 5 years. The primary
      aims is to evaluate implant quality according to recognized dosimetric parameters. Secondary
      aims include elaboration of approaches to different technical scenarios imposed by variation
      in seroma size, shape and location within the breast (expanding the technical manual to
      include recommended approaches to implants in different sectors of the breast and in
      different size breasts), incorporation of the use of live 3D ultrasound in the procedure (as
      opposed to current use of 2D US), assessment of patient acceptance and quality of life,
      physician assessment of cosmesis, assessment of toxicity, and recording of cost to the
      patient and health care system compared to alternate forms of breast radiotherapy.
    

Trial Arms

NameTypeDescriptionInterventions
Breast seed implantExperimentalStranded palladium seed interstitial radioactive seed implant to seroma with margin with 3 dimensional ultrasound and CT guidance

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Patient consent and signature of approved consent form.
    
                   -  Age greater than 55 years and postmenopausal.
    
                   -  Life expectancy of at least ten years
    
                   -  Stage 0 or I breast cancer. Tumour size < 2 cm.
    
                   -  Invasive cancer must be pathologic grade 1 or 2
    
                   -  Histology must be either Ductal Carcinoma In Situ or invasive ductal
                      adenocarcinoma of the breast.
    
                   -  Tumour removed by lumpectomy with clear margins (DCIS and invasive).
    
                   -  Unifocal disease
    
                   -  For invasive breast cancer, axillary staging by either sentinel node biopsy or
                      axillary dissection (minimum of 6 axillary nodes). Not required for DCIS.
    
                   -  Brachytherapy generally should be performed within 16 weeks of the last surgery
                      (lumpectomy, re-excision of margins, or axillary staging procedure). If > 16
                      weeks, will be assessed on case-by-case basis, based on seroma visibility and the
                      presence of surgical clips in the tumour bed.
    
                   -  Tumour must be Estrogen Receptor positive.
    
                   -  The lumpectomy cavity (seroma) must be clearly delineated by ultrasound and CT
                      and should be < 3 cm diameter (equivalent sphere) resulting in a maximum of 125
                      cc planning target volume (PTV).
    
                   -  Breast seed implant must be considered technically deliverable by interstitial
                      brachytherapy by the attending radiation oncologist and must be a minimum 2-plane
                      implant.
    
                   -  If prior non-breast malignancies, must have been disease-free for 5 or more
                      years. Time limit waived for carcinoma in-situ of the cervix or colon, melanoma
                      in-situ, and basal or squamous cell carcinoma of the skin.
    
            Exclusion Criteria:
    
              -  Stage T2 or higher breast cancer
    
                   -  Histologically positive axillary nodes.
    
                   -  High grade (grade 3) invasive ductal carcinoma
    
                   -  Extensive DCIS
    
                   -  Lymphatic or Vascular Invasion positive
    
                   -  Significant persistent post surgical complications
    
                   -  Palpable or radiographically suspicious ipsilateral or contralateral axillary, or
                      regional nodes, unless histologically confirmed negative.
    
                   -  Suspicious microcalcifications, densities, or palpable abnormalities in the
                      ipsilateral or contralateral breast unless confirmed benign.
    
                   -  Proven multi-centric carcinoma (invasive cancer or DCIS)
    
                   -  Paget's disease of the nipple.
    
                   -  Synchronous bilateral invasive or non-invasive breast cancer.
    
                   -  History of previous ipsilateral invasive breast cancer or DCIS.
    
                   -  Surgical margins that are positive or cannot be microscopically assessed.
    
                   -  Clear delineation of the target lumpectomy cavity not possible.
    
                   -  Breast implants.
    
                   -  Prior ipsilateral breast or thoracic radiotherapy.
    
                   -  Known genetic mutation in Breast Cancer Associated (BRCA 1 or 2)
    
                   -  Collagen vascular disease,
          
    Maximum Eligible Age:80 Years
    Minimum Eligible Age:55 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Implant quality
    Time Frame:Day 0
    Safety Issue:
    Description:Post implant CT evaluation to report dosimetric parameters including the minimum dose in Gray to 90% of the target volume (D90) and the percentage of the target volume (seroma, seroma with 5 mm margin, seroma with 10 mm margin) receiving 100% of the prescribed dose (V100).

    Secondary Outcome Measures

    Measure:Eligibility for implant based on seroma size and location within breast
    Time Frame:Day 0
    Safety Issue:
    Description:US and CT evaluation to record the range of seroma volumes and quadrant location in the breast acceptable for implantation
    Measure:Feasibility of 3D US for procedure guidance
    Time Frame:Day 0
    Safety Issue:
    Description:Post implant CT evaluation describing dosimetric parameters (D90 and V100 as above in Outcome 1) with the use of 3D ultrasound and with 2D ultrasound
    Measure:Cosmesis
    Time Frame:5 years
    Safety Issue:
    Description:Physician assessed using the questionnaire from the Radiation Therapy Oncology Group (RTOG) and National Surgical Adjuvant Breast Project (NSABP)
    Measure:Toxicity
    Time Frame:5 years
    Safety Issue:
    Description:Physician assessed using the Common Terminology Criteria for Adverse Events (CTCAE V4) form
    Measure:Quality of life
    Time Frame:5 years
    Safety Issue:
    Description:Patient assessed using the RTOG/NSABP Breast Cancer Quality of Life Assessment form
    Measure:Dose to Organs at risk
    Time Frame:Day 0
    Safety Issue:
    Description:Post implant CT assessment describing calculated doses to lung, ribs and heart described as the highest dose to 1 cc of the specific organ tissue and skin dose recorded as an area 1 cm by 1 cm by 2 mm thick (1cmx1cmx0.2cm)
    Measure:Cost
    Time Frame:5 years
    Safety Issue:
    Description:Cost to health care system (Canadian dollars) and patient (expenses and lost wages in Canadian dollars)

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:British Columbia Cancer Agency

    Trial Keywords

    • breast cancer
    • brachytherapy
    • partial breast radiotherapy
    • palladium 103

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