Back to results

Adjuvant Whole Breast Radiotherapy (RT) With Intensity Modulated Radiotherapy (IMRT) and a Simultaneous Integrated Boost Versus Conventional RT and a Sequential Boost (IMRT-MC2)

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

IMRT with an simultaneous integrated boost

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring IMRT, Integrated boost, adjuvant radiotherapy, breast cancer, breast conserving surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Heidelberg, Dept. Radiation OncologyRecruiting
University of Heidelberg, Dept. Radiation Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

IMRT + integrated boost

Conventional RT + sequential boost

Arm Description

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

Outcomes

Primary Outcome Measures

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.

local recurrence rates

Secondary Outcome Measures

fraction of patients surviving (overall survival)

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

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

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

quality of life

EORTC questionnaires QLQ-C30 and QLQ-BR23

occurence of secondary malignancies

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

Full Information

NCT ID

NCT01322854

First Posted

March 24, 2011

Last Updated

April 6, 2011

Sponsor

Heidelberg University

Collaborators

DLR German Aerospace Center

1. Study Identification

Unique Protocol Identification Number

NCT01322854

Brief Title

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

Acronym

IMRT-MC2

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

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

Collaborators

DLR German Aerospace Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

502 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IMRT + integrated boost

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional RT + sequential boost

Arm Type

Other

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

IMRT with an simultaneous integrated boost

Intervention Description

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

Primary Outcome Measure Information:

Title

cosmetic results

Description

Time Frame

2 years

Title

local recurrence rates

Time Frame

5 years

Secondary Outcome Measure Information:

Title

fraction of patients surviving (overall survival)

Description

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

Time Frame

15 years

Title

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

Description

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

Time Frame

15 years

Title

quality of life

Description

EORTC questionnaires QLQ-C30 and QLQ-BR23

Time Frame

2 years

Title

occurence of secondary malignancies

Description

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

Time Frame

15 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Holger Hof, MD

Phone

+496221568202

holger.hof@med.uni-heidelberg.de

First Name & Middle Initial & Last Name or Official Title & Degree

Vasileios Askoxylakis, MD

Phone

+496221568202

vasileios.askoxylakis@med.uni-heidelberg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juergen Debus, MD, PhD

Organizational Affiliation

Heidelberg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Heidelberg, Dept. Radiation Oncology

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Holger Hof, MD

Phone

+496221568202

holger.hof@med.uni-heidelberg.de

First Name & Middle Initial & Last Name & Degree

Vasileios Askoxylakis, MD

Phone

+496221568202

vasileios.askoxylakis@med.uni-heidelberg.de

First Name & Middle Initial & Last Name & Degree

Holger Hof, MD

First Name & Middle Initial & Last Name & Degree

Juergen Debus, MD, PhD

First Name & Middle Initial & Last Name & Degree

Vasileios Askoxylakis, MD

First Name & Middle Initial & Last Name & Degree

Leonie Fetzner, MD

First Name & Middle Initial & Last Name & Degree

Matthias Haefner, MD

First Name & Middle Initial & Last Name & Degree

Jörg Heil, MD

First Name & Middle Initial & Last Name & Degree

Alexandra Jensen, MD

Facility Name

University of Heidelberg, Dept. Radiation Oncology

City

Mannheim

ZIP/Postal Code

68135

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frederik Wenz, MD

Phone

+496213833530

frederik.wenz@medma.uni-heidelberg.de

First Name & Middle Initial & Last Name & Degree

Frederik Wenz, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34480960

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.

Results Reference

derived

PubMed Identifier

33321192

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.

Results Reference

derived

PubMed Identifier

33050920

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.

Results Reference

derived

PubMed Identifier

21676232

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs