A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain
- Compare pain response at 4 and 12 weeks post-treatment in patients with localized
metastatic bone pain treated with single-dose ibandronate vs single-dose local
- Compare the quality of life of patients treated with these regimens.
- Correlate urinary markers of osteoclast activity (pyridinoline and deoxypyridinoline)
with the clinical outcome of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are
stratified according to primary tumor type and participating center. Patients are randomized
into 1 of 2 treatment arms.
- Arm I: Patients receive a single dose of local radiotherapy to the site of pain
- Arm II: Patients receive a single dose of ibandronate IV over 15 minutes. Patients who
do not achieve a partial or complete response at 4 weeks crossover to the alternate
Quality of life is assessed at baseline and then at 4 and 12 weeks. Pain is assessed at
baseline, at 4, 8, and 12 weeks, and then at 6 months.
Patients are followed at 4, 8, and 12 weeks and then at 6 and 12 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 470 patients (235 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Cancer Research UK
United States: Federal Government