Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial

Petra Braam*, Philippe Lambin, Johan Bussink

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Painful spinal metastases have been treated with conventional radiotherapy for decades, but one-third of the patients have insufficient pain relief after treatment and one-fifth need retreatment. Stereotactic radiotherapy is a method to increase the dose in the spinal metastases with a potentially longer lasting palliative effect without increasing the side effects of the treatment and thereby is expected to improve the quality of life significantly.This study is a multicenter prospective randomized clinical trial comparing conventional radiotherapy (1 x 8 Gy) with stereotactic radiotherapy (1 x 20 Gy) for pain reduction and quality of life in patients with painful spinal metastases. A total of 386 patients will be randomized between the two treatment groups. Besides pain measured by the Dutch Brief Pain Inventory, quality of life and cost-effectiveness also will be measured. The primary outcome is pain reduction at 6 weeks after treatment. Secondary outcomes will be the time to pain response, duration of pain relief, health-related quality of life and toxicity, as well as cost-effectiveness.This study investigates whether stereotactic radiotherapy with dose escalation for symptomatic spinal metastases can lead to improved pain reduction as compared to conventional radiotherapy without an increase of treatment-related side effects. These results will contribute to the optimization and individualization of the treatment for the patient.ClinicalTrials.gov identifier NCT02407795 (March 31, 2015).
Original languageEnglish
Article number61
JournalTrials
Volume17
DOIs
Publication statusPublished - 2 Feb 2016

Keywords

  • Stereotactic
  • Spinal metastases
  • SBRT
  • Pain
  • Quality of life
  • Palliative radiotherapy
  • IMRT

Cite this