Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
NCT ID: NCT00082927
Last Updated: 2013-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
580 participants
INTERVENTIONAL
2003-04-30
2011-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
NONE
Interventions
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ibandronate sodium
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed primary prostate cancer OR sclerotic bone metastases (for patients with serum prostate-specific antigen \> 100 ng/mL)
* Radiologically confirmed bone metastases by plain x-ray, isotope scan, CT scan, or MRI
* Clinical diagnosis of metastatic bone pain for which radiotherapy is indicated
* Single localized metastatic bone pain AND receiving optimal analgesics and adjuvant drugs, including non-steroidal anti-inflammatory drugs, unless contraindicated
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* Over 18
Sex
* Male
Menopausal status
* Not specified
Performance status
* Not specified
Life expectancy
* At least 3 months
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Creatinine ≤ 3.0 mg/dL
* No hypercalcemia (corrected calcium \> 10.8 mg/dL)
* No hypocalcemia (corrected calcium \< 8.2 mg/dL)
Other
* No known hypersensitivity to ibandronate or other bisphosphonates
* No history of aspirin-sensitive asthma
* Able to comply with pain chart and quality of life assessments
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* More than 4 weeks since prior change in systemic chemotherapy
* No prior high-dose chemotherapy (dose intensity \> 3 times standard dose)
Endocrine therapy
* More than 4 weeks since prior change in hormonal therapy
Radiotherapy
* See Disease Characteristics
* No prior external beam radiotherapy to index site
* No prior systemic radioisotope therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
Surgery
* Not specified
Other
* More than 6 months since prior bisphosphonate treatment
* More than 4 weeks since prior aminoglycoside antibiotics
* More than 30 days since prior investigational drugs
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Principal Investigators
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Heather Purnell
Role:
Cancer Research UK
Katherine Monson
Role:
Cancer Research UK
Locations
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William Harvey Hospital
Ashford-Kent, England, United Kingdom
North Devon District Hospital
Barnstaple, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Royal United Hospital
Bath, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Queen's Hospital
Burton-on-Trent, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Cumberland Infirmary
Carlisle, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Mayday University Hospital
Croydon, England, United Kingdom
Russells Hall Hospital
Dudley, England, United Kingdom
Eastbourne District General Hospital
Eastbourne, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Diana Princess of Wales Hospital
Grimsby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Harrogate District Hospital
Harrogate, England, United Kingdom
Kidderminster Hospital
Kidderminster Worcestershire, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Lincoln County Hospital
Lincoln, England, United Kingdom
Cancer Research UK and University College London Cancer Trials Centre
London, England, United Kingdom
Royal Marsden - London
London, England, United Kingdom
St. Mary's Hospital
London, England, United Kingdom
Charing Cross Hospital
London, England, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom
Northampton General Hospital NHS Trust
Northampton, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
King's Mills Hospital
Nottinghamshire, England, United Kingdom
George Eliot Hospital
Nuneaton, England, United Kingdom
Alexandra Healthcare NHS
Redditch, Worcestershire, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Conquest Hospital
Saint Leonards-on-Sea, England, United Kingdom
Scarborough General Hospital
Scarborough, England, United Kingdom
Scunthorpe General Hospital
Scunthorpe, England, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Musgrove Park Hospital
Taunton, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
Warrington Hospital NHS Trust
Warrington, England, United Kingdom
Warwick Hospital
Warwick, England, United Kingdom
Sandwell General Hospital
West Bromwich, England, United Kingdom
Weston General Hospital
Weston-super-Mare, England, United Kingdom
West Cumberland Hospital
Whitehaven, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Worthing Hospital
Worthing, England, United Kingdom
Yeovil District Hospital
Yeovil, England, United Kingdom
Cancer Care Centre at York Hospital
York, England, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Countries
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Other Identifiers
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CDR0000361728
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20224
Identifier Type: -
Identifier Source: secondary_id
RIB
Identifier Type: -
Identifier Source: secondary_id
ISRCTN86185157
Identifier Type: -
Identifier Source: secondary_id
CRUK-NCRI-RT-02-01
Identifier Type: -
Identifier Source: org_study_id
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