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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 ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06077071 - MRIdian "RADAR" Trial N/A
Completed NCT00634426 - Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression Phase 4
Active, not recruiting NCT01254903 - Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management in Patients With Inoperable, Previously Unirradiated Metastatic Epidural Spinal Cord Compression (MESCC) Phase 1
Completed NCT01256554 - Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression Phase 1