The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery. 502 patients will be recruited and randomized in two arms: patients in arm A will receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor-bed by an integrated boost, while patients in arm B will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 Gy and a consecutive boost in 8 fractions to a total dose of 66.4 Gy. Primary aim of the study is the assessment of the cosmetic outcome and local control after breast radiotherapy. The study hypothesis is that intensity modulated radiotherapy (IMRT) is, in spite of the reduced treatment duration, at least equivalent to conventional therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
502
IMRT in 28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed
University of Heidelberg, Dept. Radiation Oncology
Heidelberg, Germany
RECRUITINGUniversity of Heidelberg, Dept. Radiation Oncology
Mannheim, Germany
NOT_YET_RECRUITINGcosmetic results
The cosmetic outcome will be assessed by two independent investigators using the Harvard criteria (excellent, good, fair, poor). Additional parameters to be evaluated are skin color, teleangiectasy, scars, shrinking and asymmetry. Evaluation will also be carried out using a quantitative digitizer scoring system based on standardized photodocumentations of the breast, as described by Vrieling et al.. by calculation of a breast retraction assessment (BRA) score.
Time frame: 2 years
local recurrence rates
Time frame: 5 years
fraction of patients surviving (overall survival)
ratio of number of patients alive to total number of patients treated
Time frame: 15 years
fraction of patients surviving without tumor recurrence (disease-free survival)
ratio of patients alive without tumor recurrence to total number of patients treated
Time frame: 15 years
quality of life
EORTC questionnaires QLQ-C30 and QLQ-BR23
Time frame: 2 years
occurence of secondary malignancies
ratio of patients with occurence of secondary malignancies to total number of patients treated
Time frame: 15 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.