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:

Recruiting

Phase:

N/A

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:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Maisonneuve-Rosemont Hospital

    Trial Keywords

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

    Last Updated