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| Sponsor: | Cancer Research UK |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00082927 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Pain Prostate Cancer |
Drug: ibandronate sodium |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Active Control |
| Official Title: | A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain |
| Estimated Enrollment: | 580 |
| Study Start Date: | April 2003 |
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United Kingdom, England | |
| Alexandra Healthcare NHS | Recruiting |
| Redditch, Worcestershire, England, United Kingdom, B98 7UB | |
| Contact: Clive J. Irwin 44-015-2750-3030 | |
| Basingstoke and North Hampshire NHS Foundation Trust | Recruiting |
| Basingstoke, England, United Kingdom, RG24 9NA | |
| Contact: Contact Person 44-148-340-5823 | |
| Bristol Haematology and Oncology Centre | Recruiting |
| Bristol, England, United Kingdom, BS2 8ED | |
| Contact: Contact Person 44-117-928-2409 | |
| Cancer Care Centre at York Hospital | Recruiting |
| York, England, United Kingdom, Y031 8HE | |
| Contact: Contact Person 44-014-2355-5453 | |
| Cancer Research UK and University College London Cancer Trials Centre | Recruiting |
| London, England, United Kingdom, NW1 2ND | |
| Contact: Contact Person 44-207-679-8036 | |
| Charing Cross Hospital | Recruiting |
| London, England, United Kingdom, W6 8RF | |
| Contact: Simon Stewart, MD 44-20-8846-7659 s.stewart@ic.ac.ak | |
| Clatterbridge Centre for Oncology | Recruiting |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Contact: Isabel Syndikus, MD 44-151-334-1155 ext. 4748 | |
| Conquest Hospital | Recruiting |
| Saint Leonards-on-Sea, England, United Kingdom, TN37 7RD | |
| Contact: Contact Person 44-142-475-8391 | |
| Cumberland Infirmary | Recruiting |
| Carlisle, England, United Kingdom, CA2 7HY | |
| Contact: Contact Person 44-122-881-4345 | |
| Diana Princess of Wales Hospital | Recruiting |
| Grimsby, England, United Kingdom, DN33 2BA | |
| Contact: Contact Person 44-147-287-4111 | |
| Eastbourne District General Hospital | Recruiting |
| Eastbourne, England, United Kingdom, BN21 2UD | |
| Contact: Contact Person 44-132-341-7400 ext 5813 | |
| Essex County Hospital | Recruiting |
| Colchester, England, United Kingdom, C03 3NB | |
| Contact: Contact Person 44-120-6744636 | |
| George Eliot Hospital | Recruiting |
| Nuneaton, England, United Kingdom, CV10 7DJ | |
| Contact: Contact Person 44-024-769-67474 | |
| Nottingham City Hospital NHS Trust | Recruiting |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Contact: Contact Person 44-115-969-1169 ext. 54690 | |
| Kent and Canterbury Hospital | Recruiting |
| Canterbury, England, United Kingdom, CT1 3NG | |
| Contact: Contact Person 44-122-776-6877 | |
| Kidderminster Hospital | Recruiting |
| Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ | |
| Contact: Contact Person 44-156-253-802 | |
| King's Mills Hospital | Recruiting |
| Nottinghamshire, England, United Kingdom, NG17 4JL | |
| Contact: Contact Person 44-115-1169 ext. 54690 | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Contact Person 44-113-392-4206 | |
| Lincoln County Hospital | Recruiting |
| Lincoln, England, United Kingdom, LN2 5QY | |
| Contact: Thiagarajan Sreenivasant 44-152-257-7203 | |
| Mayday University Hospital | Recruiting |
| Croydon, England, United Kingdom | |
| Contact: Contact Person 44-208-661-3269 | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
| Northwood, England, United Kingdom, HA6 2RN | |
| Contact: Peter J. Hoskin, MD 44-019-2384-4533 | |
| Musgrove Park Hospital | Recruiting |
| Taunton, England, United Kingdom, TA1 5DA | |
| Contact: Contact Person 44-0182-334-2418 | |
| New Cross Hospital | Recruiting |
| Wolverhampton, England, United Kingdom, WV10 0QP | |
| Contact: Contact Person 44-019-0269-5207 | |
| North Devon District Hospital | Recruiting |
| Barnstaple, England, United Kingdom, EX31 4JB | |
| Contact: Contact Person 44-127-131-1538 | |
| Northampton General Hospital NHS Trust | Recruiting |
| Northampton, England, United Kingdom, NN1 5BD | |
| Contact: Contact Person 44-160-454-5246 | |
| Harrogate District Hospital | Recruiting |
| Harrogate, England, United Kingdom, HG2 7SX | |
| Contact: Contact Person 44-142-355-5453 | |
| Oldchurch Hospital | Recruiting |
| Romford, England, United Kingdom, RM7 OBE | |
| Contact: A. Alsafer, MD 44-1708-746-090 | |
| Queen's Hospital | Recruiting |
| Burton-upon-Trent, England, United Kingdom, DE13 0RB | |
| Contact: Contact Person 44-128-356-6333 ext. 5465 | |
| Royal Devon and Exeter Hospital | Recruiting |
| Exeter, England, United Kingdom, EX2 5DW | |
| Contact: Denise J. Sheehan, MD 44-1392-411-611 | |
| Royal Marsden - London | Recruiting |
| London, England, United Kingdom, SW3 6JJ | |
| Contact: Contact Person 44-1392-411-611 | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Alan Horwich, MD, PhD, FRCP, FRCR 44-20-8661-3274 | |
| Royal Shrewsbury Hospital | Recruiting |
| Shrewsbury, England, United Kingdom, SY3 8XQ | |
| Contact: Contact Person 44-0174-326-1656 | |
| Royal United Hospital | Recruiting |
| Bath, England, United Kingdom, BA1 3NG | |
| Contact: Contact Person 44-122-582-1522 | |
| St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting |
| Guildford, England, United Kingdom, GU2 7XX | |
| Contact: Marianne Illsley 44-1483-571-122 | |
| Sandwell General Hospital | Recruiting |
| West Bromwich, England, United Kingdom, B71 4HJ | |
| Contact: Conact Person 44-012-1472-1311 | |
| Scarborough General Hospital | Recruiting |
| Scarborough, England, United Kingdom, YO12 6QL | |
| Contact: Contact Person 44-014-270-1151 | |
| Scunthorpe General Hospital | Recruiting |
| Scunthorpe, England, United Kingdom, DN15 7BH | |
| Contact: Contact Person 44-172-429-0180 | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Contact Person 44-238-079-8657 | |
| Russells Hall Hospital | Recruiting |
| Dudley, England, United Kingdom, DY1 2HQ | |
| Contact: Contact Person 44-128-484-5611 ext. 2219 | |
| St. Mary's Hospital | Recruiting |
| London, England, United Kingdom, W2 1NY | |
| Contact: Contact Person 44-207-886-1132 | |
| Sussex Cancer Centre at Royal Sussex County Hospital | Recruiting |
| Brighton, England, United Kingdom, BN2 5BF | |
| Contact: David Bloomfield, MD 44-1273-696-955 ext. 7686 | |
| Torbay Hospital | Recruiting |
| Torquay, England, United Kingdom, TQ2 7AA | |
| Contact: Contact Person 44-018-0365-5381 | |
| Walsgrave Hospital | Recruiting |
| Coventry, England, United Kingdom, CV2 2DX | |
| Contact: Contact Person 44-24-7653-5986 | |
| West Cumberland Hospital | Recruiting |
| Whitehaven, England, United Kingdom, CA28 8JG | |
| Contact: Contact Person 44-122-881-4245 | |
| Warwick Hospital | Recruiting |
| Warwick, England, United Kingdom, CV34 5BW | |
| Contact: Contact Person 44-247-96-7483 | |
| Warrington Hospital NHS Trust | Recruiting |
| Warrington, England, United Kingdom, WA5 1QG | |
| Contact: Contact Person 44-015-334-1155 ext. 4801 | |
| Weston General Hospital | Recruiting |
| Weston-super-Mare, England, United Kingdom, BS23 4TQ | |
| Contact: Contact Person 44-019-3464-7186 | |
| William Harvey Hospital | Recruiting |
| Ashford-Kent, England, United Kingdom, TN24 0LZ | |
| Contact: Contact Person 44-122-776-6877 | |
| Worthing Hospital | Recruiting |
| Worthing, England, United Kingdom, BN11 2DH | |
| Contact: Contact Person 44-019-032-5111 ext. 4225 | |
| Yeovil District Hospital | Recruiting |
| Yeovil, England, United Kingdom, BA21 4AT | |
| Contact: Contact Person 44-011-7928-2419 | |
| United Kingdom, Scotland | |
| Ninewells Hospital | Recruiting |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Contact: Contact Person 44-138-242-5543 | |
| United Kingdom, Wales | |
| Glan Clwyd Hospital | Recruiting |
| Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ | |
| Contact: Contact Person 44-017-4544-5155 | |
| Investigator: | Heather Purnell | Cancer Research UK |
| Investigator: | Katherine Monson | Cancer Research UK |
More Information
| Study ID Numbers: | CDR0000361728, CRUK-NCRI-RT-02-01, EU-20224, RIB, ISRCTN86185157 |
| Study First Received: | May 14, 2004 |
| Last Updated: | June 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00082927 History of Changes |
| Health Authority: | Unspecified |
|
stage IV prostate cancer bone metastases pain recurrent prostate cancer |
|
Genital Neoplasms, Male Prostatic Diseases Physiological Effects of Drugs Urogenital Neoplasms Bone Density Conservation Agents Genital Diseases, Male Pharmacologic Actions |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Ibandronic acid Neoplasm Metastasis Prostatic Neoplasms |