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

Conditions

Breast Cancer

Keywords

IMRT, Integrated boost, adjuvant radiotherapy, breast cancer, breast conserving surgery

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.

Forster T, Köhler C, Dorn M, Häfner MF, Arians N, König L, Harrabi SB, Schlampp I, Weykamp F, Meixner E, Lang K, Heinrich V, Weidner N, Hüsing J, Wallwiener M, Golatta M, Hennigs A, Heil J, Hof H, Krug D, Debus J, Hörner-Rieber J.

2023-05-266 citations

10.1016/j.ijrobp.2023.05.035

Quality of Life After Simultaneously Integrated Boost With Intensity-Modulated vs. Conventional Radiotherapy Followed by Sequential Boost for Adjuvant Treatment of Breast Cancer: 2-Year Results of the Multicenter Randomized IMRT-MC2 Trial.

Forster T, Hommertgen A, Häfner MF, Arians N, Laila K, Harrabi S, Schlampp I, Köhler C, Heinrich V, Weidner N, Hüsing J, Golatta M, Sohn C, Heil J, Hof H, Krug D, Debus J, Hoerner-Rieber J.

2021-11-01

10.1016/j.ijrobp.2021.07.105

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).

Hörner-Rieber J, Forster T, Hommertgen A, Haefner MF, Arians N, König L, Harrabi SB, Schlampp I, Weykamp F, Lischalk JW, Heinrich V, Weidner N, Hüsing J, Sohn C, Heil J, Hof H, Krug D, Debus J.

2020-12-1345 citations

10.1016/j.ijrobp.2020.12.005

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.

Krug D, Köder C, Häfner MF, Arians N, Harrabi SB, Koerber SA, Forster T, Schlampp I, Sohn C, Heil J, Hof H, Hörner-Rieber J, Debus J.

2020-10-1311 citations

10.1186/s13014-020-01652-x

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

Askoxylakis V, Jensen AD, Häfner MF, Fetzner L, Sterzing F, Heil J, Sohn C, Hüsing J, Tiefenbacher U, Wenz F, Debus J, Hof H.

2011-06-1521 citations

10.1186/1471-2407-11-249

Interventions

RADIATIONIMRT with an simultaneous integrated boost

IMRT in 28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
cosmetic results	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	5 years	—

Secondary

Measure	Time frame	Description
fraction of patients surviving (overall survival)	15 years	ratio of number of patients alive to total number of patients treated
fraction of patients surviving without tumor recurrence (disease-free survival)	15 years	ratio of patients alive without tumor recurrence to total number of patients treated
quality of life	2 years	EORTC questionnaires QLQ-C30 and QLQ-BR23
occurence of secondary malignancies	15 years	ratio of patients with occurence of secondary malignancies to total number of patients treated

Countries

Germany

Contacts

Primary ContactHolger Hof, MD

holger.hof@med.uni-heidelberg.de+496221568202

Backup ContactVasileios Askoxylakis, MD

vasileios.askoxylakis@med.uni-heidelberg.de+496221568202

Outcome results

None listed