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

Primary Purpose

Metastatic Epidural Spinal Cord Compression

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
radiotherapy
Sponsored by
Prof. Dirk Rades, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Epidural Spinal Cord Compression focused on measuring metastatic epidural spinal cord compression, motor function, ambulatory status, pain, quality of life, overall survival, local control, toxicity

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic
  • Oberschwabenklinik Ravensburg
  • Klinikum Bayreuth
  • University of Regensburg
  • University of Würzburg
  • Ruhr University
  • Radiotherapy Practice Dresden-Friedrichstadt
  • University of Lübeck
  • Charite Berlin
  • Center of Radiotherapy and Radiation Oncology
  • Institute of Oncology, Vilnius University
  • Saad Specialist Hospital
  • Institute of Oncology
  • Consorcio Hospitalario Provencial de Castellon
  • Cruces University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5 x 4 Gy in 1 week

10 x 3 Gy in 2 weeks

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants Showing Improvement or no Further Progression of Motor Deficits 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

Number of Participants Who Were Able to Walk 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..
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
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.
Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline
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.
Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline
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.
Number of Participants Who Were Alive at 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.
Number of Participants Showing Improvement of Motor Deficits 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.
Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity
Toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4)

Full Information

First Posted
July 7, 2014
Last Updated
February 18, 2020
Sponsor
Prof. Dirk Rades, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02189473
Brief Title
Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression
Acronym
SCORE-2
Official Title
Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression (10 x 3 Gy Versus 5 x 4 Gy)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dirk Rades, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Epidural Spinal Cord Compression
Keywords
metastatic epidural spinal cord compression, motor function, ambulatory status, pain, quality of life, overall survival, local control, toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 x 4 Gy in 1 week
Arm Type
Experimental
Arm Description
radiotherapy with 5 x 4 Gy in 1 week (5 x 4 Gy per week)
Arm Title
10 x 3 Gy in 2 weeks
Arm Type
Active Comparator
Arm Description
radiotherapy with 10 x 3 Gy in 2 weeks (5 x 3 Gy per week)
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)
Primary Outcome Measure Information:
Title
Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy
Description
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).
Time Frame
at 1 month following radiotherapy
Secondary Outcome Measure Information:
Title
Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy
Description
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..
Time Frame
at 1 month following radiotherapy
Title
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
Description
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.
Time Frame
6 months following radiotherapy
Title
Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline
Description
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.
Time Frame
at 1 month following radiotherapy
Title
Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline
Description
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.
Time Frame
at 1 month following radiotherapy
Title
Number of Participants Who Were Alive at 6 Months Following Radiotherapy
Description
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.
Time Frame
6 months following radiotherapy
Title
Number of Participants Showing Improvement of Motor Deficits at 1 Month Following Radiotherapy
Description
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.
Time Frame
at 1 month following radiotherapy
Title
Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity
Description
Toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4)
Time Frame
during radiotherapy and up to 6 months following radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Rades, MD
Organizational Affiliation
Department of Radiation Oncology, University of Lübeck, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Oberschwabenklinik Ravensburg
City
Ravensburg
State/Province
Baden-Wutemberg
ZIP/Postal Code
88191
Country
Germany
Facility Name
Klinikum Bayreuth
City
Bayreuth
State/Province
Bavaria
ZIP/Postal Code
95445
Country
Germany
Facility Name
University of Regensburg
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
University of Würzburg
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany
Facility Name
Ruhr University
City
Bochum
State/Province
North Rhine Westphalia
ZIP/Postal Code
44801
Country
Germany
Facility Name
Radiotherapy Practice Dresden-Friedrichstadt
City
Dresden
State/Province
Saxonia
ZIP/Postal Code
01067
Country
Germany
Facility Name
University of Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Charite Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Center of Radiotherapy and Radiation Oncology
City
Bremen
ZIP/Postal Code
28239
Country
Germany
Facility Name
Institute of Oncology, Vilnius University
City
Vilnius
Country
Lithuania
Facility Name
Saad Specialist Hospital
City
Khobar
Country
Saudi Arabia
Facility Name
Institute of Oncology
City
Ljubljana
Country
Slovenia
Facility Name
Consorcio Hospitalario Provencial de Castellon
City
Valencia
State/Province
Castellon
Country
Spain
Facility Name
Cruces University Hospital
City
Barakaldo
State/Province
Vizcaya (Basque Country)
ZIP/Postal Code
48903
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression

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