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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01322854
• Other study ID #: IMRT-MC2
• Status: Recruiting
• Phase: Phase 3
• First received: March 24, 2011
• Last updated: April 6, 2011
• Start date: March 2011
• Est. completion date: March 2018

Study information

• Verified date: February 2011
• Source: Heidelberg University
• Contact: Holger Hof, MD
• Phone: +496221568202
• Email: holger.hof[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 502
• Est. completion date: March 2018
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	University of Heidelberg, Dept. Radiation Oncology	Heidelberg
Germany	University of Heidelberg, Dept. Radiation Oncology	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	DLR German Aerospace Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	Yes
Primary	local recurrence rates		5 years	Yes
Secondary	fraction of patients surviving (overall survival)	ratio of number of patients alive to total number of patients treated	15 years	Yes
Secondary	fraction of patients surviving without tumor recurrence (disease-free survival)	ratio of patients alive without tumor recurrence to total number of patients treated	15 years	Yes
Secondary	quality of life	EORTC questionnaires QLQ-C30 and QLQ-BR23	2 years	Yes
Secondary	occurence of secondary malignancies	ratio of patients with occurence of secondary malignancies to total number of patients treated	15 years	Yes