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NCT Number: NCT02000518

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

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.

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Key information

Conditions

Neurological Outcome Survival From First Diagnosis Metastatic Spinal Cord Compression to Death

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Heidelberg, Departement radiation oncology

Heidelberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External Beam Radiotherapy

Radiation

Primary outcomes

  1. neurological outcome

    Time frame: 6 weeks after end of radiotherapy

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

Secondary outcomes

  1. local control

    Time frame: 6 weeks after end of radiotherapy

    according CT scan, local control will be assessed

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Acronym: CK-INF

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 4, 2013
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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