Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
- Conditions
- Metastatic CancerPainProstate Cancer
- Registration Number
- NCT00082927
- Lead Sponsor
- Cancer Research UK
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 580
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (52)
Cancer Care Centre at York Hospital
🇬🇧York, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
West Cumberland Hospital
🇬🇧Whitehaven, England, United Kingdom
Warwick Hospital
🇬🇧Warwick, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, England, United Kingdom
King's Mills Hospital
🇬🇧Nottinghamshire, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, England, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, England, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom
Eastbourne District General Hospital
🇬🇧Eastbourne, England, United Kingdom
Harrogate District Hospital
🇬🇧Harrogate, England, United Kingdom
Kidderminster Hospital
🇬🇧Kidderminster Worcestershire, England, United Kingdom
Cancer Research UK and University College London Cancer Trials Centre
🇬🇧London, England, United Kingdom
St. Mary's Hospital
🇬🇧London, England, United Kingdom
George Eliot Hospital
🇬🇧Nuneaton, England, United Kingdom
Alexandra Healthcare NHS
🇬🇧Redditch, Worcestershire, England, United Kingdom
Scarborough General Hospital
🇬🇧Scarborough, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Warrington Hospital NHS Trust
🇬🇧Warrington, England, United Kingdom
Sandwell General Hospital
🇬🇧West Bromwich, England, United Kingdom
Weston General Hospital
🇬🇧Weston-super-Mare, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
Mayday University Hospital
🇬🇧Croydon, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Conquest Hospital
🇬🇧Saint Leonards-on-Sea, England, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Royal Marsden - London
🇬🇧London, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Diana Princess of Wales Hospital
🇬🇧Grimsby, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
William Harvey Hospital
🇬🇧Ashford-Kent, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Torbay Hospital
🇬🇧Torquay, England, United Kingdom
Northampton General Hospital NHS Trust
🇬🇧Northampton, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom