Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by Heidelberg University
Sponsor:
Collaborator:
DLR German Aerospace Center
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01322854
First received: March 24, 2011
Last updated: April 6, 2011
Last verified: February 2011
  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:


Further study details as provided by Heidelberg University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Heidelberg University
DLR German Aerospace Center
Investigators
Principal Investigator: Juergen Debus, MD, PhD Heidelberg University
  More Information

No publications provided by Heidelberg University

Additional 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
Study First Received: March 24, 2011
Last Updated: April 6, 2011
Health Authority: Germany: Federal Office for Radiation Protection

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

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

ClinicalTrials.gov processed this record on November 25, 2014