NCT02189473

Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Prof. Dirk Rades, MD · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Metastatic Epidural Spinal Cord Compression

Interventions

Type	Name	Description
RADIATION	radiotherapy	external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)

Timeline

• Start date: 2010-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-07-14
• Last updated: 2020-03-05
• Results posted: 2020-02-17

Locations

15 sites across 6 countries: United States, Germany, Lithuania, Saudi Arabia, Slovenia, Spain