NCT01322854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
502

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Mar 2011

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 7, 2011

Status Verified

February 1, 2011

Enrollment Period

2 years

First QC Date

March 24, 2011

Last Update Submit

April 6, 2011

Conditions

Breast Cancer

Keywords

IMRTIntegrated boostadjuvant radiotherapybreast cancerbreast conserving surgery

Outcome Measures

Primary Outcomes (2)

  • cosmetic results

    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.

    2 years

  • local recurrence rates

    5 years

Secondary Outcomes (4)

  • fraction of patients surviving (overall survival)

    15 years

  • fraction of patients surviving without tumor recurrence (disease-free survival)

    15 years

  • quality of life

    2 years

  • occurence of secondary malignancies

    15 years

Study Arms (2)

IMRT + integrated boost

EXPERIMENTAL

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

Radiation: IMRT with an simultaneous integrated boost

Conventional RT + sequential boost

OTHER

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

Radiation: IMRT with an simultaneous integrated boost

Interventions

IMRT with an simultaneous integrated boostRADIATION

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

Conventional RT + sequential boostIMRT + integrated boost

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Heidelberg, Dept. Radiation Oncology

Heidelberg, 69115, Germany

RECRUITING

University of Heidelberg, Dept. Radiation Oncology

Mannheim, 68135, Germany

NOT YET RECRUITING

Related Publications (4)

  • 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.

    PMID: 34480960DERIVED

  • 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.

    PMID: 33321192DERIVED

  • 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.

    PMID: 33050920DERIVED

  • 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.

    PMID: 21676232DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Juergen Debus, MD, PhD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Holger Hof, MD

CONTACT

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

Vasileios Askoxylakis, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2018

Last Updated

April 7, 2011

Record last verified: 2011-02

Locations

DE(2)