Clinical trial NCT02189473: Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression
Official title: Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression (10 x 3 Gy Versus 5 x 4 Gy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Epidural Spinal Cord Compression
Keywords: metastatic epidural spinal cord compression
motor function
ambulatory status
pain
quality of life
overall survival
local control
toxicity
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Motor function; additional assessments directly and at 3 and at 6 months after radiotherapy
2. Ability to walk; assessment directly and at 1, 3 and 6 months after radiotherapy
3. Sensory function; assessment directly and at 1, 3 and 6 months after radiotherapy
4. Quality of life; evaluation directly and at 1, 3 and 6 months after radiotherapy
5. Pain assessment directly and at 1, 3 and 6 months after radiotherapy
6. Overall survival up to 6 months following radiotherapy
7. Local Progression-free survival up to 6 months following radiotherapy

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

Primary outcomes:
measure: Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy
timeFrame: at 1 month following radiotherapy
Secondary outcomes:
measure: Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy
timeFrame: at 1 month following radiotherapy
measure: 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
timeFrame: 6 months following radiotherapy
measure: Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline
timeFrame: at 1 month following radiotherapy
measure: Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline
timeFrame: at 1 month following radiotherapy
measure: Number of Participants Who Were Alive at 6 Months Following Radiotherapy
timeFrame: 6 months following radiotherapy
measure: Number of Participants Showing Improvement of Motor Deficits at 1 Month Following Radiotherapy
timeFrame: at 1 month following radiotherapy
measure: Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity
timeFrame: during radiotherapy and up to 6 months following radiotherapy
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Ravensburg
country: Germany
facility: Oberschwabenklinik Ravensburg
state: Baden-Wutemberg
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
state: Bavaria
city: Regensburg
country: Germany
facility: University of Regensburg
state: Bavaria
city: Würzburg
country: Germany
facility: University of Würzburg
state: Bavaria
city: Bochum
country: Germany
facility: Ruhr University
state: North Rhine Westphalia
city: Dresden
country: Germany
facility: Radiotherapy Practice Dresden-Friedrichstadt
state: Saxonia
city: Lübeck
country: Germany
facility: University of Lübeck
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Berlin
city: Bremen
country: Germany
facility: Center of Radiotherapy and Radiation Oncology
city: Vilnius
country: Lithuania
facility: Institute of Oncology, Vilnius University
city: Khobar
country: Saudi Arabia
facility: Saad Specialist Hospital
city: Ljubljana
country: Slovenia
facility: Institute of Oncology
city: Valencia
country: Spain
facility: Consorcio Hospitalario Provencial de Castellon
state: Castellon
city: Barakaldo
country: Spain
facility: Cruces University Hospital
state: Vizcaya (Basque Country)
Study officials:
affiliation: Department of Radiation Oncology, University of Lübeck, Germany
name: Dirk Rades, MD
role: STUDY_CHAIR
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