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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Heidelberg University
- Enrollment
- 502
- Locations
- 2
- Primary Endpoint
- cosmetic results
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients aged >18 years and < 70 years after breast conserving surgery.
- •Patients aged ≥ 70 years with following risk factors:
- •Tumor stadium ≥ T2
- •Multifocal disease
- •Lymphangiosis
- •Extended intraductal component
- •Resection margin ≤3mm
Exclusion Criteria
- •Refusal of the patients to be included in the study
- •Karnofsky Performance Score ≤ 70%
- •Metastatic disease (M1)
- •Other malignancies
- •Previous radiotherapy of the breast
- •Pregnancy
Arms & Interventions
IMRT + integrated boost
28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed by an integrated boost
Intervention: IMRT with an simultaneous integrated boost (Radiation)
Conventional RT + sequential boost
Conventional radiotherapy of the whole 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
Intervention: IMRT with an simultaneous integrated boost (Radiation)
Outcomes
Primary Outcomes
cosmetic results
Time Frame: 2 years
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.
local recurrence rates
Time Frame: 5 years
Secondary Outcomes
- fraction of patients surviving (overall survival)(15 years)
- fraction of patients surviving without tumor recurrence (disease-free survival)(15 years)
- quality of life(2 years)
- occurence of secondary malignancies(15 years)