Postoperative Modulated Accelerated RAdiotherapy (MARA-1) for Early Stage Breast Cancer: a Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 447
- 主要终点
- Incidence of treatment-related late adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •confirmed histologic evidence of pTis-pT3 breast cancer
- •breast conservative surgery
- •post menopausal status
- •clear surgical margin
排除标准
- •positive or close resection margins
- •3 or more metastatic axillary nodes
- •nodal irradiation
结局指标
主要结局
Incidence of treatment-related late adverse events
时间窗: 5 years
late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients
次要结局
- Incidence of treatment-related acute adverse events(6 months)
- overall survival(5 years)
- local control(5 years)
研究者
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna