Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
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
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.
Observational Model: Case-Only, Time Perspective: Retrospective
Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy.
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
8 years post RT
Jean-Philippe Pignol, MD
Odette Cancer Centre
Canada:UBC BCCA Research Ethics Board.