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临床试验/NCT02000518
NCT02000518已完成不适用

Phase 1 Study of Neurological Outcome After Emergency Radiotherapy in Metastatic Spinal Cord Compression

Heidelberg University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
neurological outcome

研究概览

简要总结

Acute neurological deficit in metastatic spinal cord compression is an emergency condition in radiation oncology. Despite some reports about the high efficacy of radiation treatment for oncological emergencies, a standard of care is not well defined, especially the time interval of immediate RT after deficit, and neurological outcome with respect to poor survival in non-small cell lung cancer patients. The objective of this trial is to investigate neurological outcome after emergency radiotherapy in metastatic spinal cord compression of non-small cell lung cancer patients with acute neurological deficit.

详细描述

Subjects and recruitment 15 consecutive patients with histologically confirmed non-small cell lung cancer and bone metastases of the thoracic or lumbar segments of the vertebral column will be screened for this trial in the Radiooncology Department of the Heidelberg University Clinic. Inclusion criteria are an age of 18 to 80 years, acute neurological symptom caused by metastatic spinal cord compression, no radiotherapy in this spinal area before, and written consent to participate.

Design and procedures This is a prospective, controlled, explorative trial to investigate the neurological outcome after emergency radiotherapy in metastatic spinal cord compression of non-small cell lung cancer patients with acute neurological deficit. RT start within 12 hours after onset of neurological symptoms. The target parameters will be measured at the start of radiotherapy (t0), and six weeks after radiotherapy (RT) (t1). The target parameters comprise the documentation and completion of the ASIA Impairment Scale (AIS), and the recording of patient-specific data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria are an age of 18 to 80 years, acute neurological symptom caused by metastatic spinal cord compression, no RT in this spinal area before, and written consent to participate.

排除标准

  • neurological symptom more than 12 hours before

结局指标

主要结局

neurological outcome

时间窗: 6 weeks after end of radiotherapy

The primary endpoint was neurological outcome, assessed using the ASIA Impairment Scale (AIS)

次要结局

  • local control(6 weeks after end of radiotherapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra Jensen

Neurological outcome after emergency radiotherapy in MSCC of patients with non-small cell lung cancer

Heidelberg University

研究点 (1)

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