Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02189473
• Date of registration: 07/07/2014
• Prospective Registration: No
• Primary sponsor: Prof. Dirk Rades, MD
• Public title: Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression SCORE-2
• Scientific title: Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression (10 x 3 Gy Versus 5 x 4 Gy)
• Date of first enrolment: July 2010
• Target sample size: 203
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02189473
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany, Lithuania, Saudi Arabia, Slovenia, Spain, United States

Contacts

• Name: Dirk Rades, MD
• Affiliation: Department of Radiation Oncology, University of Lübeck, Germany

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metastatic Epidural Spinal Cord Compression

Intervention(s)

Radiation: radiotherapy

Primary Outcome(s)

Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy [Time Frame: at 1 month following radiotherapy]

Secondary Outcome(s)

Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline [Time Frame: at 1 month following radiotherapy]

Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity [Time Frame: during radiotherapy and up to 6 months following radiotherapy]

Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy [Time Frame: at 1 month following radiotherapy]

Number of Participants Showing Improvement of Motor Deficits at 1 Month Following Radiotherapy [Time Frame: at 1 month following radiotherapy]

Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline [Time Frame: at 1 month following radiotherapy]

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]

Number of Participants Who Were Alive at 6 Months Following Radiotherapy [Time Frame: 6 months following radiotherapy]

Secondary ID(s)

ARO 200901

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02189473