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Breast CancerPhase 3IMRT-MC2NCT01322854

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

A Phase 3 study testing IMRT with an simultaneous integrated boost in people with Breast Cancer, run by Heidelberg University at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
IMRT with an simultaneous integrated boost
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
2 sitesGermany
Study dates
Mar 2011to Mar 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Holger Hof, MD contact

+496221568202

holger.hof@med.uni-heidelberg.de

Vasileios Askoxylakis, MD contact

+496221568202

vasileios.askoxylakis@med.uni-heidelberg.de

Germany2 sites, 2 recruiting

  • University of Heidelberg, Dept. Radiation Oncology

    Heidelberg, 69115

    Holger Hof, MD, +496221568202, holger.hof@med.uni-heidelberg.de

    Vasileios Askoxylakis, MD, +496221568202, vasileios.askoxylakis@med.uni-heidelberg.de

    Recruiting

  • University of Heidelberg, Dept. Radiation Oncology

    Mannheim, 68135

    Frederik Wenz, MD, +496213833530, frederik.wenz@medma.uni-heidelberg.de

    Frederik Wenz, MD

    Not yet recruiting

Other trials in Germany

About this study

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

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
Being tested
IMRT with an simultaneous integrated boost
Keywords
IMRT, Integrated boost, adjuvant radiotherapy, breast cancer, breast conserving surgery
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT01322854
Study groupRoleWhat they receive
IMRT + integrated boostExperimental28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed by an integrated boost
Receives: Radiation: IMRT with an simultaneous integrated boost
Conventional RT + sequential boostOtherConventional 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
Receives: Radiation: IMRT with an simultaneous integrated boost

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

  2. local recurrence rates

    Measured: 5 years

Secondary outcomes (4)

  1. fraction of patients surviving (overall survival)

    ratio of number of patients alive to total number of patients treated

    Measured: 15 years

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

    ratio of patients alive without tumor recurrence to total number of patients treated

    Measured: 15 years

  3. quality of life

    EORTC questionnaires QLQ-C30 and QLQ-BR23

    Measured: 2 years

  4. occurence of secondary malignancies

    ratio of patients with occurence of secondary malignancies to total number of patients treated

    Measured: 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2013 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
502 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01322854
Sponsor's protocol ID
IMRT-MC2
Acronym
IMRT-MC2
Status last verified
Feb 2011
First submitted
24 Mar 2011
Last updated
7 Apr 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34480960

  • 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.

    PubMed 33321192

  • 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.

    PubMed 33050920

  • 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.

    PubMed 21676232

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IMRT with an simultaneous integrated boost in people with Breast Cancer, run by Heidelberg University at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Holger Hof, MD (+496221568202, holger.hof@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cosmetic results (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01322854, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.

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