Modulated Accelerated RAdiotherapy in Early Breast Cancer
- Conditions
- Breast CancerRadiation Toxicity
- Registration Number
- NCT03461224
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 447
- confirmed histologic evidence of pTis-pT3 breast cancer
- breast conservative surgery
- post menopausal status
- clear surgical margin
- pT4
- positive or close resection margins
- 3 or more metastatic axillary nodes
- nodal irradiation
- M1
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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
Incidence of treatment-related acute adverse events 6 months acute toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients
overall survival 5 years defined as the time from diagnosis to death
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