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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189473
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : February 17, 2020
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Epidural Spinal Cord Compression Radiation: radiotherapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression (10 x 3 Gy Versus 5 x 4 Gy)
Study Start Date : July 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: 5 x 4 Gy in 1 week
radiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week)
Radiation: radiotherapy
external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)

Active Comparator: 10 x 3 Gy in 2 weeks
radiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week)
Radiation: radiotherapy
external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)




Primary Outcome Measures :
  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 Outcome Measures :
  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

    1. = Ambulatory without aid
    2. = Ambulatory with aid
    3. = 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)



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189473


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Germany
Oberschwabenklinik Ravensburg
Ravensburg, Baden-Wutemberg, Germany, 88191
Klinikum Bayreuth
Bayreuth, Bavaria, Germany, 95445
University of Regensburg
Regensburg, Bavaria, Germany, 93053
University of Würzburg
Würzburg, Bavaria, Germany, 97080
Ruhr University
Bochum, North Rhine Westphalia, Germany, 44801
Radiotherapy Practice Dresden-Friedrichstadt
Dresden, Saxonia, Germany, 01067
University of Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Charite Berlin
Berlin, Germany, 10117
Center of Radiotherapy and Radiation Oncology
Bremen, Germany, 28239
Lithuania
Institute of Oncology, Vilnius University
Vilnius, Lithuania
Saudi Arabia
Saad Specialist Hospital
Khobar, Saudi Arabia
Slovenia
Institute of Oncology
Ljubljana, Slovenia
Spain
Consorcio Hospitalario Provencial de Castellon
Valencia, Castellon, Spain
Cruces University Hospital
Barakaldo, Vizcaya (Basque Country), Spain, 48903
Sponsors and Collaborators
Prof. Dirk Rades, MD
Investigators
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Study Chair: Dirk Rades, MD Department of Radiation Oncology, University of Lübeck, Germany
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dirk Rades, MD, Prof. Dr. Dirk Rades. MD, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02189473    
Other Study ID Numbers: ARO 200901
First Posted: July 14, 2014    Key Record Dates
Results First Posted: February 17, 2020
Last Update Posted: March 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein:
metastatic epidural spinal cord compression
motor function
ambulatory status
pain
quality of life
overall survival
local control
toxicity
Additional relevant MeSH terms:
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Spinal Cord Compression
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries