a Feasibility Study of Accelerated Hypofractionated Radiotherapy in Node Positive Breast Cancer Patients Treated With Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- acute toxicity assessment
研究概览
简要总结
Post-operative loco-regional (LR) hypofractionated radiotherapy (Hypo-RT) is an attractive approach in locally advanced breast cancer (LABC).
详细描述
The present is a single arm phase II study assessing toxicity levels after 34 Gy/10 fxs/2 wks to the whole breast/chest wall and to the draining lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients who had undergone conservative surgery. Both acute (CTCAE v4.0) and late (LENT/SOMA) toxicity were collected. All pts but those who underwent mastectomy without reconstruction or with temporary expander were also asked to rate their cosmetic outcome according to the Harvard. Toxicity was assessed weekly during RT and then at each follow-up examination (1, 3, 6 months and then yearly).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients affected by invasive breast cancer who underwent conservative breast surgery or mastectomy and axillary dissection, followed by post operative radiotherapy at the level of the breast/chest wall, and of the supraclavicular, third axillary level +/- internal mammary chain nodes.
- •pT1-3 disease pN1-2, cT1-3 disease if neoadjuvant chemotherapy , cN + cytologically and/or histologically assessed;
- •ECOG Performance status ≤2;
- •histologically negative surgical margins
- •no distant metastases
- •no prior chest radiotherapy
- •life expectancy ≥ 5 years
- •no prior cancer
排除标准
- •Non-epithelial breast cancer (sarcoma, lymphoma etc.)
- •Metastases at the level of the internal chain mammary and / or supra-clavicular lymph nodes histologically assessed
- •pT4 neoplasms or inflammatory breast carcinoma
- •Distant metastasis
- •Concomitant chemotherapy
- •history of prior controlateral breast tumor
结局指标
主要结局
acute toxicity assessment
时间窗: 60 months
rate of acute toxicity according to CTCAE v4.0 scale
次要结局
- to evaluate late toxicity(60 months)
研究者
Paola Pinnaro
Doctor
Regina Elena Cancer Institute