Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain

June 25, 2013 updated by: Cancer Research UK

A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

580

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Ashford-Kent, England, United Kingdom, TN24 0LZ
        • William Harvey Hospital
      • Barnstaple, England, United Kingdom, EX31 4JB
        • North Devon District Hospital
      • Basingstoke, England, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire NHS Foundation Trust
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Brighton, England, United Kingdom, BN2 5BF
        • Sussex Cancer Centre at Royal Sussex County Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Burton-upon-Trent, England, United Kingdom, DE13 0RB
        • Queen's Hospital
      • Canterbury, England, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • Carlisle, England, United Kingdom, CA2 7HY
        • Cumberland Infirmary
      • Colchester, England, United Kingdom, C03 3NB
        • Essex County Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Croydon, England, United Kingdom
        • Mayday University Hospital
      • Dudley, England, United Kingdom, DY1 2HQ
        • Russells Hall Hospital
      • Eastbourne, England, United Kingdom, BN21 2UD
        • Eastbourne District General Hospital
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Grimsby, England, United Kingdom, DN33 2BA
        • Diana Princess of Wales Hospital
      • Guildford, England, United Kingdom, GU2 7XX
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
      • Harrogate, England, United Kingdom, HG2 7SX
        • Harrogate District Hospital
      • Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ
        • Kidderminster Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Lincoln, England, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden - London
      • London, England, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, England, United Kingdom, NW1 2ND
        • Cancer Research UK and University College London Cancer Trials Centre
      • London, England, United Kingdom, W2 1NY
        • St. Mary's Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
      • Northampton, England, United Kingdom, NN1 5BD
        • Northampton General Hospital NHS Trust
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Nottinghamshire, England, United Kingdom, NG17 4JL
        • King's Mills Hospital
      • Nuneaton, England, United Kingdom, CV10 7DJ
        • George Eliot Hospital
      • Redditch, Worcestershire, England, United Kingdom, B98 7UB
        • Alexandra Healthcare NHS
      • Romford, England, United Kingdom, RM7 OBE
        • Oldchurch Hospital
      • Saint Leonards-on-Sea, England, United Kingdom, TN37 7RD
        • Conquest Hospital
      • Scarborough, England, United Kingdom, YO12 6QL
        • Scarborough General Hospital
      • Scunthorpe, England, United Kingdom, DN15 7BH
        • Scunthorpe General Hospital
      • Shrewsbury, England, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden - Surrey
      • Taunton, England, United Kingdom, TA1 5DA
        • Musgrove Park Hospital
      • Torquay, England, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • Warrington, England, United Kingdom, WA5 1QG
        • Warrington Hospital NHS Trust
      • Warwick, England, United Kingdom, CV34 5BW
        • Warwick Hospital
      • West Bromwich, England, United Kingdom, B71 4HJ
        • Sandwell General Hospital
      • Weston-super-Mare, England, United Kingdom, BS23 4TQ
        • Weston General Hospital
      • Whitehaven, England, United Kingdom, CA28 8JG
        • West Cumberland Hospital
      • Wolverhampton, England, United Kingdom, WV10 0QP
        • New Cross Hospital
      • Worthing, England, United Kingdom, BN11 2DH
        • Worthing Hospital
      • Yeovil, England, United Kingdom, BA21 4AT
        • Yeovil District Hospital
      • York, England, United Kingdom, Y031 8HE
        • Cancer Care Centre at York Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital
    • Wales
      • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
        • Glan Clwyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research UK

Investigators

  • Heather Purnell, Cancer Research UK
  • Katherine Monson, Cancer Research UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

May 14, 2004

First Submitted That Met QC Criteria

May 18, 2004

First Posted (Estimate)

May 19, 2004

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRUK-NCRI-RT-02-01
  • CDR0000361728 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20224
  • RIB
  • ISRCTN86185157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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