NCT00082927

Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain

A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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 . Secondary * 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.

Conditions

• Metastatic Cancer
• Pain
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ibandronate sodium

Timeline

• Start date: 2003-04-01
• Completion: 2011-07-01
• First posted: 2004-05-19
• Last updated: 2013-06-26

Locations

52 sites across 1 country: United Kingdom