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Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03471741
Enrollment
451
Registered
2018-03-21
Start date
2001-06-01
Completion date
2017-12-31
Last updated
2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Radiation Toxicity

Keywords

breast cancer, radiotherapy, cutaneous toxicity, subcutaneous toxicity, local control, IMRT

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.

Interventions

RADIATIONIMRT with concomitant boost
RADIATION3D-RT with sequential boost

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of treatment.related late adverse events5 yearslate toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients

Secondary

MeasureTime frameDescription
Local control5 yearsabsence of locoregional relapse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026