MedDataX Logo

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

NCT ID: NCT02000518

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

emergency radiotherapy MSCC spine neurological outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

external beam radiotherapy

emergency radiotherapy within 12 hours after neurological deficit due to MSCC

external beam radiotherapy

Intervention Type RADIATION

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

external beam radiotherapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* neurological symptom more than 12 hours before
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alexandra Jensen

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University hospital of Heidelberg, Departement radiation oncology

Heidelberg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Rades D, Fehlauer F, Schulte R, Veninga T, Stalpers LJ, Basic H, Bajrovic A, Hoskin PJ, Tribius S, Wildfang I, Rudat V, Engenhart-Cabilic R, Karstens JH, Alberti W, Dunst J, Schild SE. Prognostic factors for local control and survival after radiotherapy of metastatic spinal cord compression. J Clin Oncol. 2006 Jul 20;24(21):3388-93. doi: 10.1200/JCO.2005.05.0542.

Reference Type BACKGROUND
PMID: 16849752 (View on PubMed)

Bach F, Larsen BH, Rohde K, Borgesen SE, Gjerris F, Boge-Rasmussen T, Agerlin N, Rasmusson B, Stjernholm P, Sorensen PS. Metastatic spinal cord compression. Occurrence, symptoms, clinical presentations and prognosis in 398 patients with spinal cord compression. Acta Neurochir (Wien). 1990;107(1-2):37-43. doi: 10.1007/BF01402610.

Reference Type BACKGROUND
PMID: 2096606 (View on PubMed)

Christian E, Adamietz IA, Willich N, Schafer U, Micke O; German Working Group Palliative Radiotherapy; German Society for Radiation Oncology (DEGRO). Radiotherapy in oncological emergencies--final results of a patterns of care study in Germany, Austria and Switzerland. Acta Oncol. 2008;47(1):81-9. doi: 10.1080/02841860701481554.

Reference Type BACKGROUND
PMID: 17851852 (View on PubMed)

Rief H, Heinhold RC, Petersen LC, Rieken S, Bruckner T, Moghaddam-Alvandi A, Debus J, Sterzing F. Neurological outcome after emergency radiotherapy in MSCC of patients with non-small cell lung cancer--a prospective trial. Radiat Oncol. 2013 Dec 28;8:297. doi: 10.1186/1748-717X-8-297.

Reference Type DERIVED
PMID: 24373638 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S-514/2011

Identifier Type: -

Identifier Source: org_study_id