Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression — SCORE-2  

Metastatic Epidural Spinal Cord Compression Clinical Trial

Official title: Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression (10 x 3 Gy Versus 5 x 4 Gy)

Status Completed

Clinical Trial Summary

The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression.

Clinical Trial Description

The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression. The response rate (improvement in motor function or prevention of progression) will be assessed at one month following radiotherapy.

In addition, the following endpoints will be evaluated:

1. Motor function; additional assessments directly and at 3 and at 6 months after radiotherapy

2. Ability to walk; assessment directly and at 1, 3 and 6 months after radiotherapy

3. Sensory function; assessment directly and at 1, 3 and 6 months after radiotherapy

4. Quality of life; evaluation directly and at 1, 3 and 6 months after radiotherapy

5. Pain assessment directly and at 1, 3 and 6 months after radiotherapy

6. Overall survival up to 6 months following radiotherapy

7. Local Progression-free survival up to 6 months following radiotherapy ;

Related Conditions & MeSH terms

• Metastatic Epidural Spinal Cord Compression
• Spinal Cord Compression

• NCT number: NCT02189473
• Study type: Interventional
• Source: University of Schleswig-Holstein
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Completion date: July 2015