Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)

Conditions
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Spinal Metastases

Intervention / Treatment
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* Radiation: conventional radiotherapy
* Radiation: stereotactic radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Conventional radiotherapy, 1x8Gy | Radiation: conventional radiotherapy<br>* 1x8Gy<br>|
| Experimental: Arm 2<br>Stereotactic radiotherapy, 1x20Gy | Radiation: stereotactic radiotherapy<br>* 1x20Gy or equivalent dose fractionation schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire | Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire | At six weeks since baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of time to pain response | Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire | 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 | 
| Duration of pain relief | Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire | 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 | 
| Quality of life | EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires | 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 | 
| Toxicity measured by CTCAE 4.0 questionnaire | Toxicity measuredCTCAE 4.0 questionnaire | up to months 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic radiotherapy, pain reduction, quality of life