Clinical Trials /

Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer

NCT01717261

Description:

The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.

Related Conditions:
  • Breast Invasive Ductal Carcinoma
Recruiting Status:

Unknown status

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT01717261

Trial Eligibility

Document

Title

  • Brief Title: Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
  • Official Title:

Clinical Trial IDs

  • ORG STUDY ID: 12030
  • NCT ID: NCT01717261

Conditions

  • Breast Cancer

Purpose

The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.

Trial Arms

NameTypeDescriptionInterventions
Single Pre-Operative Radiation TherapyExperimental

    Eligibility Criteria

            Inclusion Criteria:

          -  Female aged 60 years or older.

          -  Invasive ductal carcinoma.

          -  Unifocal disease.

          -  Tumors less than 2cm.

          -  No clinical evidence of nodal disease.

          -  Estrogen receptor status (ER) positive.

          -  Her2 negative.

        Exclusion Criteria:

          -  Age less than 60 years.

          -  BRCA 1 and/or BRCA 2 mutation.

          -  Tumour histology limited to lobular carcinoma only.

          -  Neoadjuvant hormonal manipulation or chemotherapy.

          -  More than one primary tumour in different quadrants of the same breast.

          -  Inability to view tumor on imaging.
    Maximum Eligible Age:N/A
    Minimum Eligible Age:60 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Acute toxicity
    Time Frame:6 months
    Safety Issue:
    Description:Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.

    Secondary Outcome Measures

    Measure:Chronic toxicity
    Time Frame:2 years
    Safety Issue:
    Description:Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale
    Measure:Cosmetic outcome
    Time Frame:5 years
    Safety Issue:
    Description:Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Unknown status
    Lead Sponsor:Maisonneuve-Rosemont Hospital

    Trial Keywords

    • breast cancer
    • early breast cancer
    • partial breast irradiation
    • preoperative radiation

    Last Updated

    April 12, 2019