Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
RATIONALE: Ibandronate may be effective in reducing bone pain caused by metastatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether ibandronate is more effective than standard treatment with radiation therapy in treating metastatic bone pain.
PURPOSE: This phase III randomized clinical trial is studying ibandronate to see how well it works compared to single-dose local radiation therapy in treating patients with localized metastatic bone pain.
|Metastatic Cancer Pain Prostate Cancer||Drug: ibandronate sodium||Phase 3|
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain|
|Study Start Date:||April 2003|
|Study Completion Date:||July 2011|
- 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 radiotherapy .
- 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 (8Gy/1f).
- 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 arm.
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 study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082927
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|OverallOfficial:||Heather Purnell||Cancer Research UK|
|OverallOfficial:||Katherine Monson||Cancer Research UK|