Spinal Cord Compression Due to Metastasis to Spine Clinical Trial
— PRE-MODEOfficial title:
High-precision Radiotherapy of Motor Deficits Due to Metastatic Spinal Cord Compression
Verified date | February 2020 |
Source | University of Schleswig-Holstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | February 28, 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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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 |
Lead Sponsor | Collaborator |
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University of Schleswig-Holstein |
Germany,
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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 | 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. |
6 months after the end of radiotherapy | |
Secondary | Number of Participants Showing Improvement of Motor Deficits Following Radiotherapy (Best Response) | 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 = Ambulatory without aid = Ambulatory with aid = Not ambulatory = Complete paraplegia [Tomita T, et al., Acta Radiol Oncol 1983;22:135-143.] |
up to 6 months following radiotherapy | |
Secondary | Number of Participants Showing Improvement of Sensory Function Following Radiotherapy (Best Response) | Sensory function was evaluated with the following scale, modified in accordance to the classification of the American Spinal Injury Association. 0 = Absent = Impaired = Normal 9 = Cannot be assessed [Baskin DS. Spinal cord injury. In Evans RW (Ed.), Neurology and trauma, WB Saunders, Philadelphia;1996, pp. 276-299.] |
up to 6 months following radiotherapy | |
Secondary | Number of Participants Showing Improvement of Sphincter Dysfunction Following Radiotherapy (Best Response) | Sphincter dysfunction was rates as yes (presence of sphincter dysfunction) or no (absence of sphincter dysfunction). | up to 6 months following radiotherapy | |
Secondary | 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 | 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. |
3 months after the end of radiotherapy | |
Secondary | 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. | 6 months after the end of radiotherapy | |
Secondary | Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline | 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. |
Evaluation at 1 month following radiotherapy | |
Secondary | 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. |
Evaluation at 1 month following radiotherapy | |
Secondary | 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) | during radiotherapy and up to 6 months following radiotherapy | |
Secondary | Number of Participants Who Were Able to Walk 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. |
up to 6 months following radiotherapy |
Status | Clinical Trial | Phase | |
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Recruiting |
NCT04043156 -
RAdiotherapy for Metastatic Spinal Cord Compression With Increased Radiation dosES
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N/A |