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Completed

NCT Number: NCT02189473

Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression

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.

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Key information

Conditions

Metastatic Epidural Spinal Cord Compression Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oberschwabenklinik Ravensburg, Ravensburg, Baden-Wutemberg, Germany

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About this study

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:

  • Motor function; additional assessments directly and at 3 and at 6 months after radiotherapy
  • Ability to walk; assessment directly and at 1, 3 and 6 months after radiotherapy
  • Sensory function; assessment directly and at 1, 3 and 6 months after radiotherapy
  • Quality of life; evaluation directly and at 1, 3 and 6 months after radiotherapy
  • Pain assessment directly and at 1, 3 and 6 months after radiotherapy
  • Overall survival up to 6 months following radiotherapy
  • Local Progression-free survival up to 6 months following radiotherapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)

Primary outcomes

  1. Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy

    Time frame: at 1 month following radiotherapy

    Overall response was defined as improvement or no further progression of motor deficits following radiotherapy.

    Motor function was graded with the following 8-point scale: 0, complete paraplegia; 1, palpable or visible muscle contractions; 2, active movement of the leg without gravity; 3, active movement against gravity; 4, active movement against mild resistance; 5, active movement against intermediate resistance; 6, active movement against strong resistance; and 7, normal strength.

    Motor function was recorded separately for each leg resulting in total points of 0 to 14. Improvement of motor function was defined as an increase by at least 2 points compared to baseline. No further progression was defined as +/-1 point (i.e. +1 point, +/- 0 points or -1 point).

Secondary outcomes

  1. Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy

    Time frame: at 1 month following radiotherapy

    Ambulatory status was assessed using the following scoring system:

    0 = Normal strength

    • = Ambulatory without aid
    • = Ambulatory with aid
    • = Not ambulatory

    A patient with a score equal to or less than 2 is considered "able to walk". Both participants that could and could not walk prior to radiotherapy have been included in this assessment..

  2. Number of Participants Who Were Alive at 6 Months Following Radiotherapy Without Deterioration of Motor Function During (or Directly Following) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy

    Time frame: 6 months following radiotherapy

    Local Progression Free Survival (LPFS) was defined as freedom from progression of motor deficits during or one month following radiotherapy and freedom from in-field recurrence of metastatic spinal cord compression (MSCC) following radiotherapy.

    An in-field recurrence was defined as a recurrence of MSCC associated with motor deficits in the region of the spinal cord that had been previously irradiated for MSCC.

    In case of clinical suspicion of sich a recurrence, a spinal MRI was performed to confirm the diagnosis. Time to in-field recurrence was calculated from the last day of radiotherapy, and the patients were followed for a maximum of 6 months after the end of radiotherapy. The values of 6-month LPFS were estimated using the Kaplan-Meier method.

  3. Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline

    Time frame: at 1 month following radiotherapy

    Distress (as an indicator of impairment of quality of life) was measured with the distress-thermometer. the patients rated their level of distress on a scale ranging from 0 (no distress) to 10 (extreme distress). Patients rated the distress they experienced during the last week and stated the reasons for distress from a list of items.

    An improvement (lower score) by 2 points was considered a clinically relevant relief of distress. Patients with baseline-scores of 0-1 points were not included, since improvement by 2 points was not possible.

  4. Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline

    Time frame: at 1 month following radiotherapy

    Pain was measured with a numeric self-rating scale ranging from 0 (no pain) to 10 (worst pain).

    Relief of pain was defined as improvement (=decrease of pain) by at least 2 points without increase of analgesics. Patients with baseline-scores of 0-1 points were not included, since improvement by 2 points was not possible.

  5. Number of Participants Who Were Alive at 6 Months Following Radiotherapy

    Time frame: 6 months following radiotherapy

    Overall Survival (OS) was defined as freedom from death of any cause.

    Time to death was calculated from the last day of radiotherapy, and the patients were followed for a maximum of 6 months after the end of radiotherapy. The values of 6-month OS were estimated using the Kaplan-Meier method.

  6. Number of Participants Showing Improvement of Motor Deficits at 1 Month Following Radiotherapy

    Time frame: at 1 month following radiotherapy

    Motor function was graded with the following 8-point scale: 0, complete paraplegia; 1, palpable or visible muscle contractions; 2, active movement of the leg without gravity; 3, active movement against gravity; 4, active movement against mild resistance; 5, active movement against intermediate resistance; 6, active movement against strong resistance; and 7, normal strength.

    Motor function was recorded separately for each leg resulting in total points of 0 to 14. Improvement of motor function was defined as an increase by at least 2 points compared to baseline.

  7. Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity

    Time frame: during radiotherapy and up to 6 months following radiotherapy

    Toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4)

Sponsors and collaborators

Lead sponsor

Prof. Dirk Rades, MD

Other

Registry information

Official study title

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

Acronym: SCORE-2

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 14, 2014
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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