Modulated Accelerated RAdiotherapy in Early Breast Cancer

Completed

• Conditions: Breast Cancer; Radiation Toxicity
• Interventions: Radiation: conventional fractionated RT; Radiation: accelerated hypofractionated RT

• 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.

Study Timeline

• Study Start: 2001-01-10
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-09
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-03-12

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

Arm && Interventions

Group	Intervention	Description
CG: conventional fractionated RT	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
MARA-1: accelerated hypofractionated RT	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.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-related late adverse events	5 years	late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-related acute adverse events	6 months	acute toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients
overall survival	5 years	defined as the time from diagnosis to death
local control	5 years	absence of locoregional relapse