Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
In 2008 our group published the results of a multicentre, randomized, double-blinded study
comparing standard radiotherapy to breast IMRT. The study showed a significant reduction
moist desquamation using breast IMRT from 47.8% to 31.2% (p=0.002). There are two other
Phase III trials showing improvement of long term cosmetic outcomes. Yet the use of breast
IMRT remains not widely accepted. This trial aims at evaluating long term tolerance of
breast IMRT compared to standard radiotherapy.
The investigators hypothesize that breast IMRT reduces the occurence of chronic breast pain
(primary objective), improves cosmesis, reduces the occurence of delayed and permanent
radiation induced skin side effects (telangiectasia, dryness, induration, edema,
discolorations), improves quality of life. The investigators also hypothesize that there
will not be differences in the local control rate or survival.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Chronic breast pain using Visual Analog Scale
Quantitatively patients will be asked if they have spontaneous breast pain in the treated breast during the last 6 months, and will be asked to rate its intensity using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain).
8 years plus or minus one year
Jean-Philippe Pignol, MD, PhD
Sunnybrook Health Sciences Centre
Canada: Health Canada