Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain

Study Overview
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Brief Summary
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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 more effective than standard treatment with radiation therapy in treating metastatic bone pain. PURPOSE: This phase III randomized clinical trial is studying ibandronate to see how well it works compared to single-dose local radiation therapy in treating patients with localized metastatic bone pain.

Detailed Description
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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.

Official Title
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A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain

Conditions
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Metastatic Cancer, Pain, Prostate Cancer

Intervention / Treatment
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* Drug: ibandronate sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ibandronate sodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV prostate cancer, bone metastases, pain, recurrent prostate cancer