Trial Outcomes & Findings for High-precision Radiotherapy of Motor Deficits Due to Metastatic Spinal Cord Compression (NCT NCT03070431)

High-precision Radiotherapy of Motor Deficits Due to Metastatic Spinal Cord Compression

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.

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

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

Sphincter dysfunction was rates as yes (presence of sphincter dysfunction) or no (absence of sphincter dysfunction).

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.

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.

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.

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.

Toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4)

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.