Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer

Completed

• Conditions: Breast Cancer; Radiation Toxicity
• Interventions: Radiation: IMRT with concomitant boost; Radiation: 3D-RT with sequential boost

• Registration Number: NCT03471741
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

To assess feasibility of postoperative IMRT with concomitant boost in moderate-high risk breast cancer in terms of late toxicity and local control

Detailed Description

Patients treated conservatively with moderate-high risk breast cancer were treated with IMRT plus concomitant boost to surgical bed (up to a dose of 50 Gy to whole breast and 60 Gy to the tumor bed).

Aim of the study was to evaluate late toxicity and local control after this treatment compared with a historical control group (CG) of patients treated with 3D-conformal postoperative radiotherapy delivered with conventional fractionation.

Study Timeline

• Study Start: 2001-06-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-03
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-14
• Last Update Submitted: 2018-03-14
• Study First Posted: 2018-03-21
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 451

Inclusion Criteria

• histologically confirmed invasive breast cancer (pT1-4) with at least one of these characteristics: 3 or more metastatic axillary nodes, pre or peri-menopausal status, close resection margins
• breast conservative surgery

Exclusion Criteria

• positive margins
• distant metastases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MARA-2: IMRT with concomitant boost	IMRT with concomitant boost	A forward planned IMRT technique was used and the prescribed dose to the whole breast was 50 Gy plus a concomitant boost of 10 Gy to the tumor bed
CG: 3D-RT with sequential boost	3D-RT with sequential boost	The whole breast received 50.4 Gy in 28 fractions delivered with 3D-RT, followed by a sequential boost on the tumor bed of 10 Gy in 4 fractions delivered with electrons

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
Local control	5 years	absence of locoregional relapse