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

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Radiation: IMRT with an simultaneous integrated boost	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Cosmetics

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

cosmetic results [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

fraction of patients surviving (overall survival) [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]
ratio of number of patients alive to total number of patients treated
fraction of patients surviving without tumor recurrence (disease-free survival) [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]
ratio of patients alive without tumor recurrence to total number of patients treated
quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
EORTC questionnaires QLQ-C30 and QLQ-BR23
occurence of secondary malignancies [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]
ratio of patients with occurence of secondary malignancies to total number of patients treated

Estimated Enrollment:	502
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2018
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Radiation: 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
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	Radiation: 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322854

Contacts

Contact: Holger Hof, MD	+496221568202	holger.hof@med.uni-heidelberg.de
Contact: Vasileios Askoxylakis, MD	+496221568202	vasileios.askoxylakis@med.uni-heidelberg.de

Locations

Germany
University of Heidelberg, Dept. Radiation Oncology	Recruiting
Heidelberg, Germany, 69115
Contact: Holger Hof, MD +496221568202 holger.hof@med.uni-heidelberg.de
Contact: Vasileios Askoxylakis, MD +496221568202 vasileios.askoxylakis@med.uni-heidelberg.de
Sub-Investigator: Holger Hof, MD
Principal Investigator: Juergen Debus, MD, PhD
Sub-Investigator: Vasileios Askoxylakis, MD
Sub-Investigator: Leonie Fetzner, MD
Sub-Investigator: Matthias Haefner, MD
Sub-Investigator: Jörg Heil, MD
Sub-Investigator: Alexandra Jensen, MD
University of Heidelberg, Dept. Radiation Oncology	Not yet recruiting
Mannheim, Germany, 68135
Contact: Frederik Wenz, MD +496213833530 frederik.wenz@medma.uni-heidelberg.de
Principal Investigator: Frederik Wenz, MD

Sponsors and Collaborators

University of Heidelberg

DLR German Aerospace Center

Investigators

Principal Investigator:

Juergen Debus, MD, PhD

University of Heidelberg

More Information

No publications provided by University of Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Askoxylakis V, Jensen AD, Häfner MF, Fetzner L, Sterzing F, Heil J, Sohn C, Hüsing 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.

Responsible Party:	Juergen Debus, Prof. Dr. Dr., University of Heidelberg
ClinicalTrials.gov Identifier:	NCT01322854 History of Changes
Other Study ID Numbers:	IMRT-MC2
Study First Received:	March 24, 2011
Last Updated:	April 6, 2011
Health Authority:	Germany: Federal Office for Radiation Protection

Keywords provided by University of Heidelberg:

IMRT
Integrated boost
adjuvant radiotherapy
breast cancer
breast conserving surgery

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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