Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis - Prospective Trial NeoSTROBE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 4
- 主要终点
- Acute Toxicity
研究概览
简要总结
This multicentre proof-of-concept study, involving 4 centers, aims to establish the value of fractionated neoadjuvant stereotactic radiotherapy (NaSRT) as a new treatment paradigm for brain metastases (BM) in the frame of the Czech neurooncology network. Most relevant studies published to date used single-fraction radiotherapy and dealt with the inherent bias related to their retrospective nature. The researchers aim to increase the level of evidence for this treatment paradigm together with other similar ongoing studies.
详细描述
The prospective study will evaluate the efficacy and toxicity of neoadjuvant stereotactic radiotherapy (NaSRT) in patients with brain metastases (BM). Clinical data gathered will include local control (LC), the incidence of leptomeningeal disease (LMD), radiological and clinical signs of radiation necrosis (RN), overall survival, and incidence of metachronous brain metastases. The magnetic resonance imaging (MRI) characteristics of irradiated and subsequently resected BM will be obtained according to the usual protocol and specified time intervals. Clinical monitoring will comprise neurological findings, Karnofsky performance status, and quality of life (FACT-Br/EORTC QLQ-C30 questionnaire and EORTC QLQ-BN20 questionnaire. These questionnaires are designed to measure cancer patients' physical, psychological, and social functions. The questionnaires are composed of multi-item scales and single items). The data obtained from the retrospective control group (estimated for 160 patients) will include the same parameters monitored in the consecutive group of patients who underwent surgery at centers included in our study, with or without adjuvant radiotherapy (RT). Formation of this control group corresponding to the NaSRT group will enable the efficacy and risks of NaSRT to be determined in comparison with established treatment modalities.
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
盲法说明
No masking will be used in the study.
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 ≥ 18 years
- •Karnofsky Performance Status ≥ 60
- •Histologically verified primary cancer disease
- •MRI findings indicating BM
- •Target BM indicated for surgical resection and any other metastases suitable for radical SRT.
- •Target BM between 1 cm and 7 cm at the longest diameter on T1 post-contrast MR imaging
排除标准
- •Confirmed hematological malignity
- •Small-cell (lung) carcinoma
- •Peracute condition requiring immediate neurosurgical intervention
- •History of whole-brain radiotherapy (WBRT)
- •History of stereotactic radiotherapy to a target brain metastasis
- •Pregnancy
- •Inability to perform surgical resection of the target BM within 7 days after NaSRT
研究组 & 干预措施
Neoadjuvant NaSRT - prospective
Patients undergoing neoadjuvant NaSRT will be enrolled prospectively in this study arm.
干预措施: Neoadjuvant Stereotactic Radiotherapy (NaSRT) (Radiation)
Postoperative SRT - retrospective
Patients who underwent postoperative SRT in the past will be analyzed retrospectively in this study arm.
干预措施: Postoperative Stereotactic Radiotherapy (SRT) (Radiation)
结局指标
主要结局
Acute Toxicity
时间窗: 3 months
Acute Toxicity will be assessed in the study subjects according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5 to 10%.
Quality of Life Questionnaire (FACT-Br/EORTC QLQ-C30)
时间窗: 3 months
Quality of Life will be assessed in the study subjects using the FACT-Br/EORTC QLQ-C30 questionnaire.
Quality of Life Questionnaire (EORTC QLQ-BN20)
时间窗: 3 months
Quality of Life will be assessed in the study subjects using the EORTC QLQ-BN20 questionnaire.
次要结局
- Time from NaSRT to detection of LMD(3 years)
- Time from NaSRT to local progression(3 years)
- Time from NaSRT to the onset of RN(3 years)
- Overall Survival(3 years)
- Time from NaSRT to detection of distant parenchymal metastasis(3 years)