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

NCT02000518 | Completed

• 1 other identifier: S-514/2011
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

emergency radiotherapy; MSCC; spine; neurological outcome

Outcome Measures

Primary Outcomes (1)

• neurological outcome

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

  6 weeks after end of radiotherapy

Secondary Outcomes (1)

• local control

  6 weeks after end of radiotherapy

Study Arms (1)

external beam radiotherapy

emergency radiotherapy within 12 hours after neurological deficit due to MSCC

Radiation: external beam radiotherapy

Interventions

external beam radiotherapy RADIATION

external beam radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

histologically confirmed non-small cell lung cancer and bone metastases of the thoracic or lumbar segments of the vertebral column

You may not qualify if:

• neurological symptom more than 12 hours before

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University hospital of Heidelberg, Departement radiation oncology

Heidelberg, 69120, Germany

Location

Related Publications (4)

• 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.

  PMID: 16849752 BACKGROUND

• 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.

  PMID: 2096606 BACKGROUND

• 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.

  PMID: 17851852 BACKGROUND

• 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.

  PMID: 24373638 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurological outcome after emergency radiotherapy in MSCC of patients with non-small cell lung cancer

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 4, 2013
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

DE (1)