Modulated Accelerated RAdiotherapy in Early Breast Cancer

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT03461224

Collaborator

(none)

447

Enrollment

203.7

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Radiation Toxicity	Radiation: accelerated hypofractionated RT Radiation: conventional fractionated RT

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 Design

Study Type:

Observational

Actual Enrollment :

447 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Postoperative Modulated Accelerated RAdiotherapy (MARA-1) for Early Stage Breast Cancer: a Retrospective Analysis

Actual Study Start Date :

Jan 10, 2001

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.	Radiation: accelerated hypofractionated RT
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	Radiation: conventional fractionated RT

Arm

Intervention/Treatment

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.

Radiation: accelerated hypofractionated RT

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

Radiation: conventional fractionated RT

Outcome Measures

Primary Outcome Measures

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

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
local control [5 years]
absence of locoregional relapse
overall survival [5 years]
defined as the time from diagnosis to death

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Alessio G. Morganti, MD, Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy