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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014