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Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: May 14, 2004   Last Updated: June 16, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 580
Study Start Date: April 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082927

  Hide Study Locations
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        
Sponsors and Collaborators
Cancer Research UK
Investigators
Investigator: Heather Purnell Cancer Research UK
Investigator: Katherine Monson Cancer Research UK
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
bone metastases
pain
recurrent prostate cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 22, 2009