Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
Phase 1
Completed
- Conditions
- Breast Cancer
- Interventions
- Radiation: Single Pre-Operative Radiation Therapy
- Registration Number
- NCT01717261
- Lead Sponsor
- Maisonneuve-Rosemont Hospital
- Brief Summary
The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Pre-Operative Radiation Therapy Single Pre-Operative Radiation Therapy -
- Primary Outcome Measures
Name Time Method Acute toxicity 6 months Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.
- Secondary Outcome Measures
Name Time Method Chronic toxicity 2 years Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale
Cosmetic outcome 5 years Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.
Trial Locations
- Locations (1)
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada