Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression (SCORE-2)
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ClinicalTrials.gov Identifier: NCT02189473 |
Recruitment Status :
Completed
First Posted : July 14, 2014
Results First Posted : February 17, 2020
Last Update Posted : March 5, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Epidural Spinal Cord Compression | Radiation: radiotherapy | Not Applicable |
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
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)
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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) |
- 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).
- 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..
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 |
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

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
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 |
Study Chair: | Dirk Rades, MD | Department of Radiation Oncology, University of Lübeck, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
metastatic epidural spinal cord compression motor function ambulatory status pain |
quality of life overall survival local control toxicity |
Spinal Cord Compression Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Spinal Cord Injuries Wounds and Injuries |