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

NCT ID: NCT01322854

Last Updated: 2011-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2018-03-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMRT + integrated boost

28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed by an integrated boost

Group Type: EXPERIMENTAL

IMRT with an simultaneous integrated boost

Intervention Type: RADIATION

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

Conventional RT + sequential boost

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

Group Type: OTHER

IMRT with an simultaneous integrated boost

Intervention Type: RADIATION

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

Interventions

IMRT 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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

DLR German Aerospace Center

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

University of Heidelberg

Principal Investigators

Juergen Debus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

University of Heidelberg, Dept. Radiation Oncology

Heidelberg, , Germany

Site Status: RECRUITING

University of Heidelberg, Dept. Radiation Oncology

Mannheim, , Germany

Site Status: NOT_YET_RECRUITING

Countries

Germany

Central Contacts

Holger Hof, MD

Role: CONTACT

holger.hof@med.uni-heidelberg.de

+496221568202

Vasileios Askoxylakis, MD

Role: CONTACT

vasileios.askoxylakis@med.uni-heidelberg.de

+496221568202

Facility Contacts

Holger Hof, MD

Role: primary

holger.hof@med.uni-heidelberg.de

+496221568202

Vasileios Askoxylakis, MD

Role: backup

vasileios.askoxylakis@med.uni-heidelberg.de

+496221568202

Frederik Wenz, MD

Role: primary

frederik.wenz@medma.uni-heidelberg.de

+496213833530

References

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.

Reference Type: DERIVED

PMID: 34480960 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33321192 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33050920 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21676232 (View on PubMed)

Other Identifiers

IMRT-MC2

Identifier Type: -

Identifier Source: org_study_id