A Phase II Trial of Image-guided Stereotactic Body Radiation Therapy (SBRT) for Adrenal Gland Metastasis in Oligometastatic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Control of local disease
研究概览
简要总结
The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT technique in oligometastatic patients affected by adrenal gland metastases.
详细描述
This is a phase II, single arm, trial for testing efficacy of ablative high hypofractionated dose delivered with VMAT technique in oligometastatic patients with adrenal gland metastases. The potential advantages of this approach include the possibility to lead an increased local control in irradiated adrenal gland metastases. Other purpose of this study is to assess acute and late toxicity in terms of maintenance of endocrine mechanisms of hormonal production.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18years.
- •WHO performance status ≤ 1 (ECOG - KPS).
- •Histologically-proven of primary cancer disease
- •Metastases at adrenal gland radiologically proven
- •Written informed consent
排除标准
- •Prior radiation to the interested adrenal gland.
- •Patients allergic to contrast used in CT scans or who cannot be premedicated for the use of contrast.
结局指标
主要结局
Control of local disease
时间窗: 5 years
Evaluation of proportion of patients free from progression from starting radiotherapy according to CTCAE v4.03
次要结局
- Incidence of acute and late complications(5 years)
- Endocrine mechanisms of hormonal production(5 years)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas