Modulated Accelerated RAdiotherapy in Early Breast Cancer

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Breast Cancer; Radiation Toxicity

Treatments: Radiation: conventional fractionated RT; Radiation: accelerated hypofractionated RT

Study type: Observational

Funder types: Other

Identifiers

NCT03461224

MARA-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 447 patients

Sex: Female

Volunteers: No 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

Trial design

447 participants in 2 patient groups

MARA-1: accelerated hypofractionated RT

Description:

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.

Treatment:

Radiation: accelerated hypofractionated RT

CG: conventional fractionated RT

Description:

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

Treatment:

Radiation: conventional fractionated RT