Emergency Radiotherapy in Metastatic Spinal Cord Compression of Patients With Non-small Cell Lung Cancer

Completed

• Conditions: Neurological Outcome; Survival From First Diagnosis Metastatic Spinal Cord Compression to Death
• Interventions: Radiation: external beam radiotherapy

• Registration Number: NCT02000518
• Lead Sponsor: Heidelberg University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-11-26
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-03
• Last Update Submitted: 2013-12-03
• Study First Posted: 2013-12-04
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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.

Exclusion Criteria

• neurological symptom more than 12 hours before

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
external beam radiotherapy	external beam radiotherapy	emergency radiotherapy within 12 hours after neurological deficit due to MSCC

Primary Outcome Measures

Name	Time	Method
neurological outcome	6 weeks after end of radiotherapy	The primary endpoint was neurological outcome, assessed using the ASIA Impairment Scale (AIS)

Secondary Outcome Measures

Name	Time	Method
local control	6 weeks after end of radiotherapy	according CT scan, local control will be assessed

Trial Locations

Locations (1)

University hospital of Heidelberg, Departement radiation oncology; 🇩🇪 Heidelberg, Germany