ISRCTN86185157CompletedPhase 3
A multicentre randomised trial of single dose Radiotherapy compared to Ibandronate for localised metastatic Bone pain
Cancer Research UK (CRUK) (UK)0 sites580 target enrollmentStarted: June 2, 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 580
Study Overview
Brief Summary
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26242893 results
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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