Spinal Metastases
Conditions
Keywords
stereotactic radiotherapy, pain reduction, quality of life
Brief summary
A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.
Detailed description
Study population: patients with painful spinal metastases from solid tumors without spinal cord compression or cord instability. Objective: This study will test the hypothesis that stereotactic radiotherapy gives a better and longer lasting reduction of pain, local control and therewith a better quality of life. This in order to optimize and to individualize the treatment options for the patient. Study design: Complaints due to pain will be analysed using the validated Dutch Brief Pain Inventory (BPI) and side-effects will be recorded using the Common Toxicity Criteria for Adverse Events (CTCAE). In addition to this the quality of life will be analysed using the EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires. For analysis of cost-effectiveness the EQ-5D will be used.
Interventions
RADIATIONconventional radiotherapy
1x8Gy
RADIATIONstereotactic radiotherapy
1x20Gy or equivalent dose fractionation schedule
Sponsors
Koningin Wilhelmina Fonds
Maastro Clinic, The Netherlands
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* solid tumor with radiological diagnosis of spinal metastases * pain score minimum 2 on 11-point scale * maximum of 2 consecutive or noncontiguous spinal vertebra involved by tumor at current level of interest * No or mild neurological signs (radiculopathy, dermatomal sensory change and muscle strength of involved extremity) * Karnofsky performance ≥60 * WHO ≤2 * life expectancy \> 6 weeks * age ≥18 * non-pregnant, non-lactating female patients
Exclusion criteria
* history of previous radiotherapy to the spine at current level of interest * spinal instability or neurological deficit * pathological fracture or impending fracture needing fixation * prior surgery to the spine at current level of interest * clinical signs of spinal cord compression or severe neurological deficits * patients with a pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely * patients unable to undergo MRI * earlier nuclear medicine treatment * pregnancy * altered mental status that would prohibit the understanding and giving of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire | At six weeks since baseline | Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of time to pain response | pain response is calculated from the date of randomization at day 0-14, week 4, 6, and month 2, 3, 4, 6, 9, and 12 | Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire |
| Duration of pain relief | Pain relief is calculated from the date of randomization at day 0-14, week 4, 6, and month 2, 3, 4, 6, 9, and 12 | Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire |
| Quality of life | Quality of life is calculated from the date of randomization at day 0, 7, 14, week 4, 6, and month 2, 3, 4, 6, 9, and 12 | EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires |
| Toxicity measured by CTCAE 4.0 questionnaire | up to months 12 | Toxicity measuredCTCAE 4.0 questionnaire |
Countries
Netherlands
Outcome results
None listed