PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- EORTC score for erythema, telangiectasia, edema, pain
研究概览
简要总结
The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. The radiation boost is currently issued by electrons, protons or brachytherapy. These techniques require several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has an interest in reducing the number of fractions and a reduction of dose delivered to the skin.
CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for inoperable breast tumors and has proven its effectiveness and safety of treatments.
The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays issued by CK for boost to the tumor site after conventional breast irradiation.
The results, in terms of local control, will be evaluated on clinical monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •unifocal breast cancer histologically proven
- •Age> 18 years old, in good general condition (ECOG 0-2)
- •No cons-indication for radiotherapy
- •Patient who underwent lumpectomy and axillary dissection or sentinel node technique.
- •carcinoma histology ductal or lobular carcinoma
- •surgical margins microscopically without residual disease (> 1 mm)
- •tumors classes T1 or T2, N0
- •Exclusion criteria
- •residual calcifications on X-ray examination
- •Inflammatory breast cancer, ductal (and / or in situ) and invasive lobular
- •multifocal breast Cancer
- •prior Breast radiotherapy
- •Patient who received chemotherapy
排除标准
- 未提供
结局指标
主要结局
EORTC score for erythema, telangiectasia, edema, pain
时间窗: 2 months
early skin toxicity evaluation by clinical examination (radiation oncology and dermatologist) using EORTC score for erythema, telangiectasia, edema, pain.
次要结局
未报告次要终点