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ISRCTN
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ISRCTN86185157
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ClinicalTrials.gov identifier
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NCT00082927
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Public title
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A multicentre randomised trial of single dose Radiotherapy compared to Ibandronate for localised metastatic Bone pain
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Scientific title
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Acronym
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RIB
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Serial number at source
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C2422/A3027
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Study hypothesis
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The current standard treatment for localised metastatic bone pain in the United Kingdom is single dose RadioTherapy (RT). There is also increasing evidence for, and use of, the bisphosphonate class of drugs in this setting. Their activity in bone pain from primary tumours of breast, lung and prostate has been shown in both single arm phase II studies and randomised double blind placebo controlled trials. No direct comparison between any bisphosphonate and RT has been undertaken.
The objective of this trial is to determine whether ibandronate given as a single intravenous infusion of 6 mg can give comparable rates of pain control as a single 8 Gy dose of local RT. 580 eligible patients with localised metastatic bone pain will be randomised to receive either treatment. Patients failing to achieve pain response at four weeks after initial treatment will be offered the alternate treatment arm.
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Ethics approval
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MREC approved
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Study design
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Multicentre randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Localised metastatic bone pain
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Participants - inclusion criteria
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1. Histologically or cytologically proven underlying primary malignancy of breast, lung or prostate, or sclerotic bone metastases in a patient presenting with a serum Prostate Specific Antigen (PSA) more than 100ng/ml
2. Bone metastases confirmed radiologically on plain x-ray, isotope scan, Computed Tomography (CT) or Magnetic Resonance (MR) scan
3. Single localised metastatic bone pain receiving optimal analgesics and adjuvant drugs including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) unless contraindicated.
4. Clinical diagnosis of metastatic bone pain for which radiotherapy is indicated
5. Aged over 18 yrs with no upper age limit
6. Able to comply with pain chart and quality of life assessments
7. Able to give written informed consent.
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Participants - exclusion criteria
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1. Predicted life expectancy less than three months
2. Bisphosphonate treatment within the last six months
3. Any previous treatment that contraindicated radiotherapy or ibandronate or that would interfere with the action of either
4. Unfit to receive radiotherapy and ibandronate
5. Aspirin sensitive asthma in past medical history
6. Pregnancy and lactation
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Anticipated start date
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01/04/2003
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Anticipated end date
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31/12/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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580
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Interventions
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There are two trial groups:
Group 1 will be given a single dose of radiotherapy.
Group 2 will be given a single dose of Ibandronate intravenously over one to two hours.
There will be systematic patient reported measurements of pain (which will be measured using a patient-completed pain assessment questionnaire based on the Wisconsin Brief Pain Inventory and adapted by the Radiation Therapy Oncology Group [RTOG] for bone pain), and quality of life (which will be measured using the Functional Assessment of Chronic Illness Therapy [FACIT] scale).
Please note that as of 06/08/09 the end date of this trial has been extended. The initial end date was 31/08/08.
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Primary outcome measure(s)
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Pain response at four and 12 weeks post treatment. Formal definition of response includes pain score and analgesic use to achieve complete or partial response.
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Secondary outcome measure(s)
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Quality of life and bone morbidity events including retreatment for bone pain, pathological fracture and spinal cord compression.
In addition, osteoclast activity will be measured using the urinary markers pyridinoline and deoxypyridinoline, and the relation of changing levels after treatment with response will be explored.
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Sources of funding
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1. Cancer Research UK (CRUK( (UK)
2. Roche (UK) - have committed to providing free ibandronate
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Trial website
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Publications
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Contact name
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Dr
PJ
Hoskin
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Address
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Mount Vernon Hospital
Rickmansworth Road
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City/town
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Northwood
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Zip/Postcode
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UKHA6 2RN
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Country
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United Kingdom
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Tel
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+44 020 7679 8036
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Fax
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+44 020 7679 8041
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Email
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rib@ctc.ucl.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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P.O. Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 020 7317 5186
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Fax
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+44 020 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancerresearch.org.uk
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Date applied
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02/06/2003
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Last edited
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06/08/2009
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Date ISRCTN assigned
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02/06/2003
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