Clinical trial NCT01322854: Adjuvant Whole Breast Radiotherapy (RT) With Intensity Modulated Radiotherapy (IMRT) and a Simultaneous Integrated Boost Versus Conventional RT and a Sequential Boost
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: IMRT
Integrated boost
adjuvant radiotherapy
breast cancer
breast conserving surgery
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: DLR German Aerospace Center
First posted: 2011-03-25
Enrollment: 502
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: cosmetic results
timeFrame: 2 years
measure: local recurrence rates
timeFrame: 5 years
Secondary outcomes:
measure: fraction of patients surviving (overall survival)
timeFrame: 15 years
measure: fraction of patients surviving without tumor recurrence (disease-free survival)
timeFrame: 15 years
measure: quality of life
timeFrame: 2 years
measure: occurence of secondary malignancies
timeFrame: 15 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Dept. Radiation Oncology
city: Mannheim
country: Germany
facility: University of Heidelberg, Dept. Radiation Oncology
Study officials:
affiliation: Heidelberg University
name: Juergen Debus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forster T, Hommertgen A, Hafner MF, Arians N, Konig L, Harrabi SB, Schlampp I, Kohler C, Meixner E, Heinrich V, Weidner N, Husing J, Sohn C, Heil J, Golatta M, Hof H, Krug D, Debus J, Horner-Rieber J. Quality of life after simultaneously integrated boost with intensity-modulated versus conventional radiotherapy with sequential boost for adjuvant treatment of breast cancer: 2-year results of the multicenter randomized IMRT-MC2 trial. Radiother Oncol. 2021 Oct;163:165-176. doi: 10.1016/j.radonc.2021.08.019. Epub 2021 Sep 1.
citation: Horner-Rieber J, Forster T, Hommertgen A, Haefner MF, Arians N, Konig L, Harrabi SB, Schlampp I, Weykamp F, Lischalk JW, Heinrich V, Weidner N, Husing J, Sohn C, Heil J, Hof H, Krug D, Debus J. Intensity Modulated Radiation Therapy (IMRT) With Simultaneously Integrated Boost Shortens Treatment Time and Is Noninferior to Conventional Radiation Therapy Followed by Sequential Boost in Adjuvant Breast Cancer Treatment: Results of a Large Randomized Phase III Trial (IMRT-MC2 Trial). Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1311-1324. doi: 10.1016/j.ijrobp.2020.12.005. Epub 2020 Dec 13.
citation: Krug D, Koder C, Hafner MF, Arians N, Harrabi SB, Koerber SA, Forster T, Schlampp I, Sohn C, Heil J, Hof H, Horner-Rieber J, Debus J. Acute toxicity of normofractionated intensity modulated radiotherapy with simultaneous integrated boost compared to three-dimensional conformal radiotherapy with sequential boost in the adjuvant treatment of breast cancer. Radiat Oncol. 2020 Oct 13;15(1):235. doi: 10.1186/s13014-020-01652-x.
citation: Askoxylakis V, Jensen AD, Hafner MF, Fetzner L, Sterzing F, Heil J, Sohn C, Husing J, Tiefenbacher U, Wenz F, Debus J, Hof H. Simultaneous integrated boost for adjuvant treatment of breast cancer--intensity modulated vs. conventional radiotherapy: the IMRT-MC2 trial. BMC Cancer. 2011 Jun 15;11:249. doi: 10.1186/1471-2407-11-249.