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

Prof. Dirk Rades, MD

Status: Completed

Conditions: Metastatic Epidural Spinal Cord Compression

Treatments: Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02189473

ARO 200901

Details and patient eligibility

About

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.

Full 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

Enrollment: 203 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Motor deficits of the lower extremities resulting from metastatic epidural spinal cord compression, which have persisted for no longer than 30 days
• Confirmation of diagnosis by magnetic resonance imaging (spinal computed tomography allowed)
• Relatively poor survival prognosis (defined as ≤35 points on the survival score published in Cancer 2008)
• Written informed consent

Exclusion criteria

• Prior radiotherapy or surgery of the spinal areas affected by MESCC
• History of symptomatic brain tumor or symptomatic brain metastases
• Metastases of the cervical spine only
• Other severe neurological disorders
• Pregnancy, Lactation
• Indication for decompressive surgery + stabilization of the affected spinal areas

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 2 patient groups

5 x 4 Gy in 1 week

Experimental group

Description:

radiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week)

Treatment:

Radiation: radiotherapy

10 x 3 Gy in 2 weeks

Active Comparator group

Description:

radiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week)

Treatment:

Radiation: radiotherapy