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Clinical Trials/NCT01717261
NCT01717261
Completed
Phase 1

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

Maisonneuve-Rosemont Hospital1 site in 1 country10 target enrollmentAugust 2012
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ConditionsBreast Cancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Maisonneuve-Rosemont Hospital
Enrollment
10
Locations
1
Primary Endpoint
Acute toxicity
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
October 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Yassa

Radiation Oncologist

Maisonneuve-Rosemont Hospital

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.

Outcomes

Primary Outcomes

Acute toxicity

Time Frame: 6 months

Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.

Secondary Outcomes

  • Chronic toxicity(2 years)
  • Cosmetic outcome(5 years)

Study Sites (1)

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