Efficacy and Safety of Fractionated Stereotactic Radiotherapy (FSRT) in Comparison to Single Session Radiosurgery in Patients With Larger Brain Metastases (2-4 cm)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 382
- 试验地点
- 26
- 主要终点
- Time to local progression - TTLP
研究概览
简要总结
Phase III trial comparing local control and side effects after fractionated stereotactic radiotherapy and single session radiosurgery in patients with larger brain metastases (2-4 cm)
详细描述
This is a prospective, multicenter randomized trial comparing local control and side effects after fractionated stereotactic radiotherapy with 12 x 4 Gy and single session radiosurgery according to RTOG 9005 in patients with larger brain metastases (2-4 cm). Patients will be randomized to either fractionated stereotactic radiotherapy with 12 x 4 Gy or radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) as defined by the RTOG 9005. Randomization will be stratified by metastasis volume and histology.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age > 18 years, no upper age limit
- •Karnofsky Performance Score > 50 points
- •Expected Survival > 3 months
- •1-10 cerebral metastases of metastatic solid cancer
- •Indication for local radiotherapy
- •Patients must be able to understand the protocol and provide informed consent
排除标准
- •Whole Brain radiotherapy no longer than 6 weeks before the start of stereotactic radiotherapy or planned whole brain radiotherapy after stereotactic radiotherapy
- •Prior irradiation of the cerebral metastasis that is to be treated in the study
- •Relevant overlap of prior radiation fields with the metastasis that is to be treated in the study
- •Metastasis in the brainstem
- •Contraindication for cerebral MRI
- •Metastasis that is to be treated in the study can't be visualized in contrast-enhanced T1 MRI sequence
- •Pregnant or lactating women
- •Abuse of illicit drugs, alcohol or medication
- •Patient not able or willing to behave according to protocol
- •Participation in another clinical trial
结局指标
主要结局
Time to local progression - TTLP
时间窗: 12 months
Local progression will be defined according to the RANO-BM criteria by an increase of at least 20% in the longest diameter of the metastasis relative to nadir or baseline. In addition to the relative increase of 20% the lesion must increase by an absolute value of 5 mm or more. TTLP is defined as the time from randomization until the detection of progression as per the RANO-BM criteria. Patients will be censored if they have no signs of local progression at the time of last tumor monitoring during follow-up or at the onset of one of the following competing risk events not associated with local progression: death, lost to follow up, unauthorized non-protocol treatment of the target lesion. Confirmatory analysis of the primary endpoint variable will be performed using a p-value of p≤0.05 as the global significance level.
次要结局
- Quality of Life according to EORTC QLQ-BN20(Change from baseline to 3, 6, 12 and 24 months)
- CNS toxicity according to CTCAE v5.0(12 months)
- Overall Survival(24 months)
- Time to local progression (Volumetric RANO-BM criteria)(12 months)
- Quality of Life according to EORTC QLQ-C30(Change from baseline to 3, 6, 12 and 24 months)
- Local-Progression-Free Survival(12 months)