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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Single Pre-Operative Radiation Therapy
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, early breast cancer, partial breast irradiation, preoperative radiation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Maisonneuve-Rosemont HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Pre-Operative Radiation Therapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Chronic toxicity
Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale
Cosmetic outcome
Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.

Full Information

First Posted
October 22, 2012
Last Updated
April 10, 2019
Sponsor
Maisonneuve-Rosemont Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01717261
Brief Title
Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
Acronym
SPORT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, early breast cancer, partial breast irradiation, preoperative radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Pre-Operative Radiation Therapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Single Pre-Operative Radiation Therapy
Intervention Description
Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.
Primary Outcome Measure Information:
Title
Acute toxicity
Description
Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Chronic toxicity
Description
Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale
Time Frame
2 years
Title
Cosmetic outcome
Description
Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Ipsilateral breast cancer recurrence
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Yassa, MD
Phone
15142523425
Email
myassa.hmr@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Yassa, MD
Organizational Affiliation
Maisonneuve-Rosemon Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Roy-Huneault
Phone
5142523425
Email
lroyhuneault.hmr@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Michael Yassa, MD

12. IPD Sharing Statement

Learn more about this trial

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

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