Single-Fraction Compared With Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases

OBJECTIVES:

Primary

- Compare pain relief in patients undergoing single-fraction vs multiple-fraction
re-irradiation of painful bone metastases at 2 months after treatment.

Secondary

- Compare overall pain relief in patients treated with these regimens.

- Compare time to pain progression in patients treated with these regimens.

- Correlate initial irradiation response with pain relief after re-irradiation in these
patients.

- Compare changes in functional interference after re-irradiation using the Brief Pain
Inventory in patients treated with these regimens.

- Compare quality of life of patients treated with these regimens (patients in Canada,
France, the Netherlands, and patients registered through RTOG).

- Determine characteristics of non-responders (to both initial and re-irradiation) among
patients treated with these regimens.

- Monitor the incidence of acute severe radiation-related side effects in patients
treated with these regimens.

- Monitor the incidence of in-field pathological fractures and spinal cord compression in
patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
response to initial radiotherapy (yes vs no), initial fractionation (single fraction vs
multiple fraction), and participating center. Patients are randomized to 1 of 2 treatment
arms.

- Arm I: Patients receive single-fraction radiotherapy (8Gy) on day 1.

- Arm II: Patients receive multiple-fraction radiotherapy (to a total of 20Gy) once daily
on days 1-5 or on days 1-8 if re-irradiation of the spine and/or whole pelvis is
involved AND prior initial radiotherapy was given in multiple fractions.

At least 4 weeks after the first re-treatment, patients in both arms may receive a second
re-treatment.

Patients complete a Brief Pain Inventory questionnaire at baseline, on days 7 and 14,
monthly during months 1-6, and at months 9 and 12. Acute Toxicities are assessed on days 7
and 14. Quality of Life is assessed at baseline and then monthly during months 1-6.

Patients are followed for up to 1 year.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study.