A Randomized Trial Comparing the Efficacy of Single Radiation Fraction with Fractionated Radiation Therapy in the Palliation of Skeletal Metastases

William Levin, MD
OncoLink Assistant Editor
Last Modified: October 24, 2000

Presenter: P. Kirkbride
Affiliation: Princess Margaret Hospital, Toronto, Canada


  • Controversy exists about whether painful bone metastases can be palliated equally well by short hypofractionated radiation therapy regimens as by more prolonged radiation therapy (RT).

  • This randomized study was primarily designed to compare the efficacy of two treatment regimens, using an endpoint which incorporated analgesic use into its assessment.

Materials and Methods:

  • 398 patients with skeletal metastases were randomized to receive either 20 Gy in 5 fractions or 8 Gy in a single fraction.

  • The primary endpoint was clinically significant pain relief at 3 months after treatment, defined as reduction in pain score at the treated site with reduced analgesics, or a pain score of zero at the treated site at 3 months without increase in analgesics.

  • Patients with painful bone metastases from any primary tumor site were eligible for study if their expected survival was at least 4 months.

  • Primary tumor sites were the breast, lung, and prostate.


  • Of the 398 patients enrolled, 287 patients were eligible for evaluation of response.

  • 111 patients were inevaluable (mostly due to death occurring before 3 months after treatment).

  • The commonest sites of treatment were spine (120 pts. - 30%) and pelvis (116 pts. - 29%)

  • 46% of patients (57/124) who received fractionated treatment achieved significant pain relief as compared to 32% (44/137) of patients treated with a single fraction (p = 0.03).

Authors' Conclusions

  • The results indicate that 20 Gy given over 5 fractions is superior (using a 3 month pain control endpoint) to a single fraction of 8 Gy in the management of patients with painful bony metastatic disease.

  • The large percentage of inevaluable patients in this study indicates how poor physicians are at estimating duration of survival in patients with metastatic disease.

Clinical/Scientific Implications:

  • Although single fraction therapy for palliation of bone metastases may be preferable to fractionated regimens with respect to allocation of resources, cost, and time of therapy, extended course therapy may be superior for pain relief.