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

This study is currently recruiting participants.
Verified October 2012 by Maisonneuve-Rosemont Hospital
Sponsor:
Information provided by (Responsible Party):
Michael Yassa, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT01717261
First received: October 22, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Breast Cancer
Radiation: Single Pre-Operative Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • Acute toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.


Secondary Outcome Measures:
  • Chronic toxicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale

  • Cosmetic outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.


Other Outcome Measures:
  • Ipsilateral breast cancer recurrence [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Pre-Operative Radiation Therapy Radiation: Single Pre-Operative Radiation Therapy
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717261

Contacts
Contact: Michael Yassa, MD 15142523425 myassa.hmr@ssss.gouv.qc.ca

Locations
Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Linda Roy-Huneault    5142523425    lroyhuneault.hmr@ssss.gouv.qc.ca   
Principal Investigator: Michael Yassa, MD         
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
Study Chair: Michael Yassa, MD Maisonneuve-Rosemon Hospital
  More Information

No publications provided

Responsible Party: Michael Yassa, Radiation Oncologist, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01717261     History of Changes
Other Study ID Numbers: 12030
Study First Received: October 22, 2012
Last Updated: October 26, 2012
Health Authority: Canada: Institutional Review Board

Keywords provided by Maisonneuve-Rosemont Hospital:
breast cancer
early breast cancer
partial breast irradiation
preoperative radiation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014