Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

451 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-06-01

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Breast Cancer Radiation Toxicity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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MARA-2: 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

IMRT with concomitant boost

Intervention Type RADIATION

CG: 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

3D-RT with sequential boost

Intervention Type RADIATION

Interventions

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IMRT with concomitant boost

Intervention Type RADIATION

3D-RT with sequential boost

Intervention Type RADIATION

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Alessio Giuseppe Morganti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessio G Morganti, MD

Role: PRINCIPAL_INVESTIGATOR

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy