Modulated Accelerated RAdiotherapy in Early Breast Cancer

IRCCS Azienda Ospedaliero-Universitaria di Bologna447 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

447

Conditions

Breast Cancer Radiation Toxicity

Interventions

accelerated hypofractionated RTRADIATION

conventional fractionated RTRADIATION

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of treatment-related late adverse events

late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients

Time frame: 5 years

Secondary Outcomes

Incidence of treatment-related acute adverse events

acute toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients

Time frame: 6 months

local control

absence of locoregional relapse

Time frame: 5 years

overall survival

defined as the time from diagnosis to death

Time frame: 5 years

Data from ClinicalTrials.gov

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