Stereotactic Radiosurgery or Hypofractionated Image-Guided Radiotherapy to the Surgical Cavity After Resection of Brain Metastases: a Multicenter, Single Arm, Open-label, Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 12
- 主要终点
- Relapse rate
研究概览
简要总结
Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases
详细描述
Patients with limited number of brain metastases from solid tumors are at high risk of local recurrence after surgical removal of the tumor mass. The standard Whole-brain radiotherapy (WBRT) demonstrated to reduce the risk of recurrence without improving survival. At the same time WBRT have substantial acute and late toxicity. Preliminary experiences with Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity indicate promising local control and good tolerance. This attitude was only partially explored in prospective trials. In this research patients with limited number of brain metastases and controlled systemic disease will be treated, with such a stereotactic irradiation, at the same time with evaluation of the local control (Primary endpoint) by repeated MRI and of quality of life, neurologic functionning (with a battery of thsts, e.g. MMSE, QLQ-C30, EORTC BN-20) as well as overall survival as secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patient underwent surgery for single brain metastasis arising from solid neoplasia (lung, breast, melanoma, kidney, colorectal), with initial histological diagnosis, or selected cases with a resected lesion and a further non-resected lesion (from 1 to 2 lesions), treatable with SRS / IGRT of the surgical cavity
- •Patient ≥ 18 years
- •Willngness to participate in the study, written informed consent
- •Performance Status according to WHO 0-I
- •Good general conditions and organ function
- •Newly diagnosed chemotherapy-naïve disease or controlled systemic disease
- •Good bone marrow, renal and hepatic function
- •Stable steroid dose or reduced for at least 5 days
排除标准
- •History of previous brain irradiation
- •Pregnancy or breastfeeding
- •Histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy
结局指标
主要结局
Relapse rate
时间窗: 1 year
Evaluate the recurrence probability in the surgical cavity after radiotherapy
次要结局
- Time to neurological progression(1 year)
- Quality of life assessment(1 year)
- Overall survival(1 year)
- Time to systemic progression(1 year)
研究者
Gianfranco Angelo Pesce
MD
Oncology Institute of Southern Switzerland