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Open Access Study protocol

Simultaneous integrated boost for adjuvant treatment of breast cancer- intensity modulated vs. conventional radiotherapy: The IMRT-MC2 trial

Vasileios Askoxylakis1*, Alexandra D Jensen1, Matthias F Häfner1, Leonie Fetzner1, Florian Sterzing1, Joerg Heil2, Christof Sohn2, Johannes Hüsing3, Uta Tiefenbacher4, Frederik Wenz4, Jürgen Debus1 and Holger Hof1

Author Affiliations

1 Department of Radiation Oncology, University of Heidelberg, INF 400, 69120, Heidelberg, Germany

2 University Breast Center, Department of Gynecology, University of Heidelberg, Vossstr. 9, 69115 Heidelberg, Germany

3 Coordination Centre for Clinical Trials, University of Heidelberg, Vossstr. 2, 69115 Heidelberg, Germany

4 Department of Radiation Oncology, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68135 Mannheim, Germany

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BMC Cancer 2011, 11:249  doi:10.1186/1471-2407-11-249

Published: 15 June 2011

Abstract

Background

Radiation therapy is an essential modality in the treatment of breast cancer. Addition of radiotherapy to surgery has significantly increased local control and survival rates of the disease. However, radiotherapy is also associated with side effects, such as tissue fibrosis or enhanced vascular morbidity. Modern radiotherapy strategies, such as intensity modulated radiotherapy (IMRT), can shorten the overall treatment time by integration of the additional tumor bed boost significantly. To what extent this might be possible without impairing treatment outcome and cosmetic results remains to be clarified.

Methods/Design

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 into 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 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 consecutive boost in 8 fractions to a total dose of 66.4 Gy.

Discussion

Primary objectives of the study are the evaluation of the cosmetic results 6 weeks and 2 years post treatment and the 2- and 5-year local recurrence rates for the two different radiotherapy strategies. Secondary objectives are long term overall survival, disease free survival and quality of life.

Trial Registration

ClinicalTrials.gov Protocol ID: NCT01322854.