Adjuvant Whole Breast Radiotherapy (RT) With Intensity Modulated Radiotherapy (IMRT) and a Simultaneous Integrated Boost Versus Conventional RT and a Sequential Boost

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: IMRT with an simultaneous integrated boost


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT + integrated boost<br>28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed by an integrated boost | Radiation: IMRT with an simultaneous integrated boost<br>* IMRT in 28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed<br>|
| Other: Conventional RT + sequential boost<br>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 | Radiation: IMRT with an simultaneous integrated boost<br>* IMRT in 28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cosmetic 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. | 2 years | 
| local recurrence rates |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fraction of patients surviving (overall survival) | ratio of number of patients alive to total number of patients treated | 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 | 15 years | 
| quality of life | EORTC questionnaires QLQ-C30 and QLQ-BR23 | 2 years | 
| occurence of secondary malignancies | ratio of patients with occurence of secondary malignancies to total number of patients treated | 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMRT, Integrated boost, adjuvant radiotherapy, breast cancer, breast conserving surgery