A multicentre randomised trial of single dose Radiotherapy compared to Ibandronate for localised metastatic Bone pai

Phase 3

Completed

• Conditions: ocalised metastatic bone pain; Cancer

• Registration Number: ISRCTN86185157
• Lead Sponsor: Cancer Research UK (CRUK) (UK)

Brief Summary

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26242893 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-06-02
• Study Completion: 2009-12-31
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 580

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain response at 4 and 12 weeks post treatment. Formal definition of response includes pain score and analgesic use to achieve complete or partial response.

Secondary Outcome Measures

Name	Time	Method
<br> Quality of life and bone morbidity events including retreatment for bone pain, pathological fracture and spinal cord compression.<br><br> 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.<br>