Prospective Randomised Multicenter Trial on Single Fraction Radiotherapy (8 Gy X 1) Versus Multiple Fractions (3 Gy X 10) in the Treatment of Painful Bone Metastases

Radiother Oncol. 2006 Jun;79(3):278-84. doi: 10.1016/j.radonc.2006.05.006. Epub 2006 Jun 21.

Abstract

Background and purpose: To investigate whether single-fraction radiotherapy is equal to multiple fractions in the treatment of painful metastases.

Patients and methods: The study planned to recruit 1000 patients with painful bone metastases from four Norwegian and six Swedish hospitals. Patients were randomized to single-fraction (8 Gy x 1) or multiple-fraction (3 Gy x 10) radiotherapy. The primary endpoint of the study was pain relief, with fatigue and global quality of life as the secondary endpoints.

Results: The data monitoring committee recommended closure of the study after 376 patients had been recruited because interim analyses indicated that, as in two other recently published trials, the treatment groups had similar outcomes. Both groups experienced similar pain relief within the first 4 months, and this was maintained throughout the 28-week follow-up. No differences were found for fatigue and global quality of life. Survival was similar in both groups, with median survival of 8-9 months.

Conclusions: Single-fraction 8 Gy and multiple-fraction radiotherapy provide similar pain benefit. These results, confirming those of other studies, indicate that single-fraction 8 Gy should be standard management policy for these patients.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Analgesics / therapeutic use
  • Bone Neoplasms / complications
  • Bone Neoplasms / radiotherapy*
  • Bone Neoplasms / secondary
  • Breast Neoplasms / pathology
  • Breast Neoplasms / radiotherapy*
  • Dose Fractionation, Radiation*
  • Dose-Response Relationship, Drug
  • Dose-Response Relationship, Radiation
  • Female
  • Humans
  • Lung Neoplasms / pathology
  • Lung Neoplasms / radiotherapy*
  • Male
  • Norway
  • Pain / drug therapy
  • Pain / etiology
  • Pain / radiotherapy*
  • Patient Compliance
  • Prostatic Neoplasms / pathology
  • Prostatic Neoplasms / radiotherapy*
  • Quality of Life
  • Radiotherapy, High-Energy / methods*
  • Radiotherapy, High-Energy / standards
  • Surveys and Questionnaires
  • Survival Rate
  • Sweden
  • Treatment Outcome

Substances

  • Analgesics