Moderated Accelerated RAdiotherapy (MARA-2) in Moderate-high Risk Breast Cancer: a Phase I-II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 主要终点
- Incidence of treatment.related late adverse events
研究概览
简要总结
To assess feasibility of postoperative IMRT with concomitant boost in moderate-high risk breast cancer in terms of late toxicity and local control
详细描述
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.
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
- •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
排除标准
- •positive margins
- •distant metastases
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
- Local control(5 years)
研究者
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna