Modulated Accelerated RAdiotherapy in Early Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

447 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-10

Study Completion Date

2017-12-31

Brief Summary

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This trial was a retrospective study on postoperative accelerated hypofractionated IMRT (MARA-1) in patients with early stage breast carcinoma, to compare late toxicity after this treatment and standard fractionated RT delivered with 3D-CRT.

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Detailed Description

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The aim of this study was to evaluate the clinical results in terms of late skin and subcutaneous toxicity of accelerated hypofractionated forward-planned IMRT in patients with early stage BC. Results were compared with a historical control group (CG) of patients treated with 3D-conformal postoperative RT delivered with conventional fractionation.

Conditions

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Breast Cancer Radiation Toxicity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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MARA-1: accelerated hypofractionated RT

A forward planned IMRT technique was used and the prescribed dose to the breast was 40 Gy in 16 fx with a concomitant boost of 4 Gy.

accelerated hypofractionated RT

Intervention Type RADIATION

CG: conventional fractionated RT

In the CG, the whole breast received 50.4 Gy in 28 fractions (fx) delivered with 3D-RT, followed by a sequential boost on the tumour bed of 10 Gy in 4 fx delivered with electrons

conventional fractionated RT

Intervention Type RADIATION

Interventions

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accelerated hypofractionated RT

Intervention Type RADIATION

conventional fractionated RT

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* confirmed histologic evidence of pTis-pT3 breast cancer
* breast conservative surgery
* post menopausal status
* clear surgical margin

Exclusion Criteria

* pT4
* positive or close resection margins
* 3 or more metastatic axillary nodes
* nodal irradiation
* M1

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Alessio Giuseppe Morganti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessio G. Morganti, MD

Role: PRINCIPAL_INVESTIGATOR

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy