Status:
COMPLETED
Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
Lead Sponsor:
Cancer Research UK
Conditions:
Metastatic Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 m...
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 . ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00082927
Start Date
April 1 2003
End Date
July 1 2011
Last Update
June 26 2013
Active Locations (52)
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1
William Harvey Hospital
Ashford-Kent, England, United Kingdom, TN24 0LZ
2
North Devon District Hospital
Barnstaple, England, United Kingdom, EX31 4JB
3
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
4
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG