A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain
18 Years
N/A
Both
Metastatic Cancer, Pain, Prostate Cancer
Trial Information
A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
Heather Purnell
Investigator Affiliation:
Cancer Research UK
Authority:
United States: Federal Government
Study ID:
CRUK-NCRI-RT-02-01
NCT ID:
NCT00082927
Start Date:
April 2003
Completion Date:
July 2011
Related Keywords:
- Metastatic Cancer
- Pain
- Prostate Cancer
- stage IV prostate cancer
- bone metastases
- pain
- recurrent prostate cancer
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Prostatic Neoplasms
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