Postoperative Modulated Accelerated RAdiotherapy (MARA-1) for Early Stage Breast Cancer: a Retrospective Analysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 447
- Primary Endpoint
- Incidence of treatment-related late adverse events
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria
Inclusion Criteria
- •confirmed histologic evidence of pTis-pT3 breast cancer
- •breast conservative surgery
- •post menopausal status
- •clear surgical margin
Exclusion Criteria
- •positive or close resection margins
- •3 or more metastatic axillary nodes
- •nodal irradiation
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Incidence of treatment-related acute adverse events(6 months)
- overall survival(5 years)
- local control(5 years)