Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy (BIMRT)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01537406
First received: February 15, 2012
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast compared to the non-treated breast, will be assessed. Also, the occurrence of delayed radiation treatment side effects including tiny red vessels in the skin, breast indurations (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin dryness will be captured.


Condition Intervention
Breast Cancer
Radiation: BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy. [ Time Frame: 8 years post RT ] [ Designated as safety issue: No ]
    A Self pain measurement questionnaire using Visual analog scale (VAS) The nurse coordinator will assess the subject's breast pain due to radiation using the CTCAE 4.0 scale Subjects will complete a Self pain measurement short form of the McGill pain questionnaire


Secondary Outcome Measures:
  • Does breast IMRT reduce the occurrence of late radiation therapy side effects [ Time Frame: 8 years post RT ] [ Designated as safety issue: No ]

    A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts.

    Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire


  • Does breast IMRT effect long term QOL [ Time Frame: 8 Years post RT ] [ Designated as safety issue: No ]

    A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts.

    Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire


  • Does IMRT effect local recurrence rates, overall and disease free survivals. [ Time Frame: 8 years post RT ] [ Designated as safety issue: No ]
    Data collection of local recurrences, overall and disease free survivals.


Estimated Enrollment: 314
Study Start Date: March 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY
    LONG TERM OUTCOMES OF A MULTICENTRE CONTROLLED CLINICAL TRIAL OF BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY
Detailed Description:

The Canadian breast IMRT clinical trial accrued 358 subjects between July 2003 to March 2005. Those subjects were randomised between standard radiotherapy using 2D wedge compensation and breast IMRT. Subjects were treated in Toronto, Ontario, or in Victoria, British Columbia. Subjects and assessors were carefully blinded to the treatment arm. The clinical trial was funded by the Canadian Institute for Health Research (CIHR) and one of the four objectives of the application was to "To record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast IMRT and conventional irradiation technique".

The investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with IMRT on the occurrence of late radiation therapy side-effects cosmetic outcome and Quality of Life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Breast cancer subjects treated in Toronto, Ontario, or in Victoria, British Columbia that participated in The Canadian breast IMRT clinical trial between July 2003 to March 2005.

Criteria

Inclusion Criteria:

  • Subject randomised in the initial breast IMRT randomized trial will be eligible for this new study

Exclusion Criteria:

  • Subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.
  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: NCT01537406

Locations
Canada, British Columbia
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R6V5
Canada, Ontario
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
British Columbia Cancer Agency
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jean-Philippe Pignol, MD Odette Cancer Centre
Principal Investigator: Pauline Truong, MD BCCA - Vancouver Island Cancer Centre
Principal Investigator: Ivo Olivotto, MD BCCA - Vancouver Island Cancer Centre
  More Information

No publications provided

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01537406     History of Changes
Other Study ID Numbers: BCCABreastIMRT
Study First Received: February 15, 2012
Last Updated: March 7, 2012
Health Authority: Canada:UBC BCCA Research Ethics Board.

Keywords provided by British Columbia Cancer Agency:
BREAST IRRADIATION USING INTENSITY MODULATED RADIATION THERAPY

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

ClinicalTrials.gov processed this record on August 28, 2014