Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases

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追踪信息

首次提交日期 ^ICMJE

September 26, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

January 2019

预计主要完成日期

January 2024 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Time to local progression - TTLP[ Time Frame: 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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

CNS toxicity according to CTCAE v5.0[ Time Frame: 12 months ]
CNS toxicity according to CTCAE v5.0
Time to local progression (Volumetric RANO-BM criteria)[ Time Frame: 12 months ]
Based on the RANO-BM criteria, progression is defined as an increase in volume of 72.8% or more (corresponds to a 20% increase in diameter for a perfect sphere).
Quality of Life according to EORTC QLQ-C30[ Time Frame: 24 months ]
Quality of Life according to EORTC QLQ-C30
Local-Progression-Free Survival[ Time Frame: 12 months ]
Local-Progression-Free Survival is defined like TTLP except that death not associated with local progression will not be censored but assessed as a separate event
Overall Survival[ Time Frame: 24 months ]
Overall Survival
Quality of Life according to EORTC QLQ-BN20[ Time Frame: 24 months ]
Quality of Life according to EORTC QLQ-BN20

描述性信息

简略标题 ^ICMJE

Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases

正式标题 ^ICMJE

Efficacy and Safety of Fractionated Stereotactic Radiotherapy (FSRT) in Comparison to Single Session Radiosurgery in Patients With Larger Brain Metastases (2-4 cm)

简要概况

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)

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 3

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: Prospective, multicenter, Open-Label, randomized
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Radiation: Radiosurgery
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
Radiation: Fractionated stereotactic radiotherapy
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

研究工具

Other: Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and no margin as defined by the RTOG 9005
Other: Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

302

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

January 2024

预计主要完成日期

January 2024 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Age > 18 years, no upper age limit - Karnofsky Performance Score > 50 points - Expected Survival > 3 months - 1-4 cerebral metastases of metastatic solid cancer - Indication for local radiotherapy - Patients must be able to understand the protocol and provide informed consent Exclusion Criteria: - 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 - More than 6 cerebral metastases including the patient's prior history - 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

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Germany

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

University of Erlangen-Nürnberg Medical School

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Rainer Fietkau, Prof. Universitätsklinikum Erlangen, Strahlenklinik
Principal Investigator: Florian Putz, Dr.med. Universitätsklinikum Erlangen, Strahlenklinik

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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