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

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

A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.

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.

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