title: Simultaneous integrated boost for adjuvant treatment of breast cancer--intensity modulated vs. conventional radiotherapy: the IMRT-MC2 trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Protocol ID: NCT01322854.
authors.affiliation: Department of Radiation Oncology, University of Heidelberg, INF 400, 69120, Heidelberg, Germany. vasileios.askoxylakis@med.uni-heidelberg.de
authors.forename: Vasileios
authors.initials: V
authors.lastname: Askoxylakis
authors.forename: Alexandra D
authors.initials: AD
authors.lastname: Jensen
authors.forename: Matthias F
authors.initials: MF
authors.lastname: Häfner
authors.forename: Leonie
authors.initials: L
authors.lastname: Fetzner
authors.forename: Florian
authors.initials: F
authors.lastname: Sterzing
authors.forename: Joerg
authors.initials: J
authors.lastname: Heil
authors.forename: Christof
authors.initials: C
authors.lastname: Sohn
authors.forename: Johannes
authors.initials: J
authors.lastname: Hüsing
authors.forename: Uta
authors.initials: U
authors.lastname: Tiefenbacher
authors.forename: Frederik
authors.initials: F
authors.lastname: Wenz
authors.forename: Jürgen
authors.initials: J
authors.lastname: Debus
authors.forename: Holger
authors.initials: H
authors.lastname: Hof
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000532:radiotherapy* / Q000601:surgery*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011878:Radiotherapy / Q000379:methods*; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant / Q000379:methods; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult