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

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ClinicalTrials.gov Identifier: NCT00082927
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

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 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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Pain Prostate Cancer Drug: ibandronate sodium Phase 3

Detailed Description:



  • 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 .


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 580 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain
Study Start Date : April 2003
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18


  • Male

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • At least 3 months


  • Not specified


  • Not specified


  • Creatinine ≤ 3.0 mg/dL
  • No hypercalcemia (corrected calcium > 10.8 mg/dL)
  • No hypocalcemia (corrected calcium < 8.2 mg/dL)


  • 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


Biologic therapy

  • Not specified


  • 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


  • 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)


  • Not specified


  • More than 6 months since prior bisphosphonate treatment
  • More than 4 weeks since prior aminoglycoside antibiotics
  • More than 30 days since prior investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082927

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Sponsors and Collaborators
Cancer Research UK
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OverallOfficial: Heather Purnell Cancer Research UK
OverallOfficial: Katherine Monson Cancer Research UK
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ClinicalTrials.gov Identifier: NCT00082927    
Other Study ID Numbers: CRUK-NCRI-RT-02-01
CDR0000361728 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
bone metastases
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs