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

Phase 3

• Conditions: Breast Cancer
• Interventions: Radiation: IMRT with an simultaneous integrated boost

• Registration Number: NCT01322854
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-02
• Study Start: 2011-03
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Last Update Submitted: 2011-04-06
• Last Update Posted: 2011-04-07
• Primary Completion: 2013-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 502

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMRT + integrated boost	IMRT with an simultaneous integrated boost	28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed by an integrated boost
Conventional RT + sequential boost	IMRT with an simultaneous 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

Primary Outcome Measures

Name	Time	Method
cosmetic results	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.
local recurrence rates	5 years

Secondary Outcome Measures

Name	Time	Method
fraction of patients surviving (overall survival)	15 years	ratio of number of patients alive to total number of patients treated
fraction of patients surviving without tumor recurrence (disease-free survival)	15 years	ratio of patients alive without tumor recurrence to total number of patients treated
quality of life	2 years	EORTC questionnaires QLQ-C30 and QLQ-BR23
occurence of secondary malignancies	15 years	ratio of patients with occurence of secondary malignancies to total number of patients treated

Trial Locations

Locations (1)

University of Heidelberg, Dept. Radiation Oncology; 🇩🇪 Mannheim, Germany