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Trial record 3 of 30 for:    spinal cord injury | radiation

High-precision Radiotherapy of Motor Deficits Due to Metastatic Spinal Cord Compression (PRE-MODE)

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ClinicalTrials.gov Identifier: NCT03070431
Recruitment Status : Completed
First Posted : March 3, 2017
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein

Brief Summary:
The major goal of this clinical study is to investigate to which extent high-precision radiotherapy (RT) with modern techniques can prevent progression or recurrence of motor deficits (weakness) of the legs following RT. In addition, it will be evaluated to which extent RT can lead to improvement of motor function, ambulatory status, sensory function and sphincter dysfunction, to pain relief and to improvement in quality of life, side effects and overall survival. For this purpose 44 patients who will receive modern high-precision RT treatment for the metastases on their vertebral bodies will be included into this phase 2 study. The results of the high-precision RT with a treatment of 5x5 Gray (Gy) in 1 week will be compared to data of a historical control group. The data set of the historical control group consists of more than 500 patients who received conventional RT with 5x4 Gy. The data collected in 1 week treatment will be compared. It is intended to show superiority regarding the local progression-free survival (LPFS) for the high-precision RT when compared with the conventional RT.

Condition or disease Intervention/treatment Phase
Spinal Cord Compression Due to Metastasis to Spine Radiation: High-precision RT 5x5 Gy in 1 week Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-precision Radiotherapy of Motor Deficits Due to Metastatic Spinal Cord Compression
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Arm Intervention/treatment
Experimental: High-precision RT 5x5 Gy in 1 week
Patients with motor deficits of the lower extremities due to metastatic spinal cord compression (MSCC) will receive 5x5 Gy of high-precision RT in 1 week.
Radiation: High-precision RT 5x5 Gy in 1 week
Patients included in this study will receive a high-precision radiotherapy with 5x5 Gy in 1 week




Primary Outcome Measures :
  1. Number of Participants Who Were Alive at 6 Months After Radiotherapy Without Deterioration of Motor Function During (or Directly After) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy [ Time Frame: 6 months after the end of 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.



Secondary Outcome Measures :
  1. Number of Participants Showing Improvement of Motor Deficits Following Radiotherapy (Best Response) [ Time Frame: up to 6 months following radiotherapy ]

    Motor function was evaluated using the following scale. Improvement of motor function was defined as a decrease of at least 1 point.

    0 = Normal strength

    1. = Ambulatory without aid
    2. = Ambulatory with aid
    3. = Not ambulatory
    4. = Complete paraplegia

    [Tomita T, et al., Acta Radiol Oncol 1983;22:135-143.]


  2. Number of Participants Showing Improvement of Sensory Function Following Radiotherapy (Best Response) [ Time Frame: up to 6 months following radiotherapy ]

    Sensory function was evaluated with the following scale, modified in accordance to the classification of the American Spinal Injury Association.

    0 = Absent

    1. = Impaired
    2. = Normal

    9 = Cannot be assessed

    [Baskin DS. Spinal cord injury. In Evans RW (Ed.), Neurology and trauma, WB Saunders, Philadelphia;1996, pp. 276-299.]


  3. Number of Participants Showing Improvement of Sphincter Dysfunction Following Radiotherapy (Best Response) [ Time Frame: up to 6 months following radiotherapy ]
    Sphincter dysfunction was rates as yes (presence of sphincter dysfunction) or no (absence of sphincter dysfunction).

  4. Number of Participants Who Were Alive at 3 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: 3 months after the end of 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. The values of 3-month LPFS were estimated using the Kaplan-Meier method.


  5. Number of Participants Who Were Alive at 6 Months Following Radiotherapy [ Time Frame: 6 months after the end of 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 Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline [ Time Frame: Evaluation at 1 month following radiotherapy ]

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

    Pain relief 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.


  7. Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline [ Time Frame: Evaluation 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.


  8. 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)

  9. Number of Participants Who Were Able to Walk Following Radiotherapy [ Time Frame: up to 6 months 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.




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

Inclusion Criteria:

  • Motor deficits of the lower extremities resulting from MSCC, which have persisted for no longer than 30 days
  • Confirmation of diagnosis by magnetic resonance (MR) imaging (computed tomography (CT) allowed)
  • Age 18 years or older
  • Written informed consent
  • Capacity of the patient to contract

Exclusion Criteria:

  • Previous RT or surgery of the spinal areas affected MSCC
  • Symptomatic brain tumor or symptomatic brain metastases
  • Metastases of the cervical spine only
  • Other severe neurological disorders
  • Pregnancy, lactation period
  • Indication for decompressive surgery of 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): NCT03070431


Locations
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Germany
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein, Ratzeburger Allee 160, 23562 Lübeck, Germany
Lubeck Hansestadt, Germany, 23562
Sponsors and Collaborators
University Hospital Schleswig-Holstein
Investigators
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Principal Investigator: Dirk Rades, Professor Radiation Oncology, University of Lübeck, Lübeck, Germany
  Study Documents (Full-Text)

Documents provided by Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dirk Rades, MD, Professor Dr. med., University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03070431    
Other Study ID Numbers: PRE-MODE
First Posted: March 3, 2017    Key Record Dates
Results First Posted: March 3, 2020
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein:
spinal cord compression, radiotherapy
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