Breast Cancer Clinical Trial
Official title:
Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
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.
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.
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Observational Model: Case-Only, Time Perspective: Retrospective
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