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Phase III Randomized Study of Single-Dose Local Radiotherapy Versus Ibandronate in Patients With Localized Metastatic Bone Pain
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
Basic Trial Information
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Protocol IDs
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Phase III
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Supportive care
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Active
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Over 18
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Other
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CRUK-NCRI-RT-02-01
EU-20224, RIB, ISRCTN86185157, NCT00082927
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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.
Entry Criteria Disease Characteristics:
- 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:
Prior/Concurrent Therapy:
Biologic therapy 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 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
Patient Characteristics:
Age Sex Menopausal status Performance status Life expectancy Hematopoietic Hepatic 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
Expected Enrollment 580A total of 470 patients (235 per treatment arm) will be accrued for this study. 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
Trial Contact Information
Trial Lead Organizations Cancer Research UK and University College London Cancer Trials Centre | | | | Heather Purnell, Study coordinator | | | | | Katherine Monson, Study coordinator | | | |
Trial Sites
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| United Kingdom |
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| England |
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Ashford-Kent |
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| | | | | William Harvey Hospital |
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Barnstaple |
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| | | North Devon District Hospital |
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Basingstoke |
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| | | North Hampshire Hospital |
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Bath |
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| | | Royal United Hospital |
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Brighton |
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| | | Sussex Cancer Centre at Royal Sussex County Hospital |
| | | David Bloomfield, MD | | Ph: | 44-1273-696-955 ext. 7686 | | |
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Bristol |
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| | | Bristol Haematology and Oncology Centre |
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Burton-upon-Trent |
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| | | Queen's Hospital |
| | | Contact Person | | Ph: | 44-128-356-6333 ext. 5465 | | |
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Canterbury |
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| | | Kent and Canterbury Hospital |
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Carlisle |
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| | | Cumberland Infirmary |
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Colchester |
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| | | Essex County Hospital |
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Coventry |
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| | | Walsgrave Hospital |
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Croydon |
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| | | Mayday University Hospital |
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Dudley |
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| | | Russells Hall Hospital |
| | | Contact Person | | Ph: | 44-128-484-5611 ext. 2219 | | |
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Eastbourne |
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| | | Eastbourne District General Hospital |
| | | Contact Person | | Ph: | 44-132-341-7400 ext 5813 | | |
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Exeter |
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| | | Royal Devon and Exeter Hospital |
| | | Denise Sheehan, MD | |
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Grimsby |
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| | | Diana Princess of Wales Hospital |
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Guildford |
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| | | St. Luke's Cancer Centre at Royal Surrey County Hospital |
| | | Marianne Illsley | |
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Harrogate |
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| | | Harrogate District Hospital |
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Kidderminster
Worcestershire |
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| | | Kidderminster Hospital |
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Leeds |
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| | | Leeds Cancer Centre at St. James's University Hospital |
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Lincoln |
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| | | Lincoln County Hospital |
| | | Thiagarajan Sreenivasant | |
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London |
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| | | Cancer Research UK and University College London Cancer Trials Centre |
| | | Contact Person | |
| | | Charing Cross Hospital |
| | | Simon Stewart, MD | |
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s.stewart@ic.ac.ak |
| | | Royal Marsden - London |
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| | | St. Mary's Hospital |
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Merseyside |
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| | | Clatterbridge Centre for Oncology |
| | | Isabel Syndikus, MD | | Ph: | 44-151-334-1155 ext. 4748 | | |
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Northampton |
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| | | Northampton General Hospital NHS Trust |
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Northwood |
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| | | Mount Vernon Cancer Centre at Mount Vernon Hospital |
| | | Peter Hoskin, MD | |
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Nottingham |
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| | | Nottingham City Hospital NHS Trust |
| | | Contact Person | | Ph: | 44-115-969-1169 ext. 54690 | | |
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Nottinghamshire |
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| | | King's Mills Hospital |
| | | Contact Person | | Ph: | 44-115-1169 ext. 54690 | | |
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Nuneaton |
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| | | George Eliot Hospital |
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Redditch, Worcestershire |
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| | | Alexandra Healthcare NHS |
| | | Clive Irwin | |
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Romford |
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| | | Oldchurch Hospital |
| | | A. Alsafer, MD | |
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Saint Leonards-on-Sea |
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| | | Conquest Hospital |
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Scarborough |
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| | | Scarborough General Hospital |
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Scunthorpe |
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| | | Scunthorpe General Hospital |
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Shrewsbury |
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| | | Royal Shrewsbury Hospital |
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Southampton |
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| | | Southampton General Hospital |
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Sutton |
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| | | Royal Marsden - Surrey |
| | | Alan Horwich, MD, PhD, FRCP, FRCR | |
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Taunton |
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| | | Musgrove Park Hospital |
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Torquay |
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| | | Torbay Hospital |
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Warrington |
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| | | Warrington Hospital NHS Trust |
| | | Contact Person | | Ph: | 44-015-334-1155 ext. 4801 | | |
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Warwick |
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| | | Warwick Hospital |
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West Bromwich |
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| | | Sandwell General Hospital |
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Weston-super-Mare |
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| | | Weston General Hospital |
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Whitehaven |
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| | | West Cumberland Hospital |
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Wolverhampton |
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| | | New Cross Hospital |
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Worthing |
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| | | Worthing Hospital |
| | | Contact Person | | Ph: | 44-019-032-5111 ext. 4225 | | |
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Yeovil |
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| | | Yeovil District Hospital |
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York |
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| | | Cancer Care Centre at York Hospital |
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| Scotland |
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Dundee |
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| | | | Ninewells Hospital |
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| Wales |
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Rhyl, Denbighshire |
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| | | | Glan Clwyd Hospital |
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| Registry Information | | | Official Title | | A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain | | | Trial Start Date | | 2003-04-01 | | | Registered in ClinicalTrials.gov | | NCT00082927 | | | Date Submitted to PDQ | | 2004-03-11 | | | Information Last Verified | | 2007-03-28 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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