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

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ClinicalTrials.gov Identifier: NCT01322854
Recruitment Status : Unknown
Verified February 2011 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : March 25, 2011
Last Update Posted : April 7, 2011
Sponsor:
Collaborator:
DLR German Aerospace Center
Information provided by:
Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: IMRT with an simultaneous integrated boost Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. cosmetic results [ Time Frame: 2 years ]
    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. local recurrence rates [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. fraction of patients surviving (overall survival) [ Time Frame: 15 years ]
    ratio of number of patients alive to total number of patients treated

  2. fraction of patients surviving without tumor recurrence (disease-free survival) [ Time Frame: 15 years ]
    ratio of patients alive without tumor recurrence to total number of patients treated

  3. quality of life [ Time Frame: 2 years ]
    EORTC questionnaires QLQ-C30 and QLQ-BR23

  4. occurence of secondary malignancies [ Time Frame: 15 years ]
    ratio of patients with occurence of secondary malignancies to total number of patients treated



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Heidelberg University
DLR German Aerospace Center
Investigators
Principal Investigator: Juergen Debus, MD, PhD Heidelberg University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juergen Debus, Prof. Dr. Dr., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01322854     History of Changes
Other Study ID Numbers: IMRT-MC2
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: February 2011

Keywords provided by Heidelberg University:
IMRT
Integrated boost
adjuvant radiotherapy
breast cancer
breast conserving surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases