MedPath

Modulated Accelerated RAdiotherapy in Early Breast Cancer

Completed
Conditions
Breast Cancer
Radiation Toxicity
Registration Number
NCT03461224
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
447
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of treatment-related late adverse events5 years

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

Secondary Outcome Measures
NameTimeMethod
local control5 years

absence of locoregional relapse

Incidence of treatment-related acute adverse events6 months

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

overall survival5 years

defined as the time from diagnosis to death

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.