A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of 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.
- Assess relationship between response to initial radiation and 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) over 5
days or over 8 days 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 at the discretion of the treating oncologist.
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 for
patients from participating groups.
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pain relief measured by the Brief Pain Inventory at 2 months after treatment
8.2 years
No
Edward LW Chow, MD
Study Chair
Edmond Odette Cancer Centre at Sunnybrook
Canada: Ethics Review Committee
SC20
NCT00080912
January 2004
September 2013
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