Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer

March 14, 2018 updated by: Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Moderated Accelerated RAdiotherapy (MARA-2) in Moderate-high Risk Breast Cancer: a Phase I-II Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

From 2003, all women fullfilling the inclusion criteria were treated with MARA-2 scheme

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Radiation: IMRT with concomitant boost
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
Radiation: 3D-RT with sequential boost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment.related late adverse events
Time Frame: 5 years
late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control
Time Frame: 5 years
absence of locoregional relapse
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2001

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARA-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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