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

Radboud University Medical Center

Status

Terminated

Conditions

Spinal Metastases

Treatments

Radiation: conventional radiotherapy

Radiation: stereotactic radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02407795

NL45994.091.14

Details and patient eligibility

About

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

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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