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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00082927
First Posted: May 19, 2004
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention Phase
Metastatic Cancer Pain Prostate Cancer Drug: ibandronate sodium Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 580
Study Start Date: April 2003
Study Completion Date: July 2011
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 .

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


  Show 52 Study Locations
Sponsors and Collaborators
Cancer Research UK
Investigators
OverallOfficial: Heather Purnell Cancer Research UK
OverallOfficial: Katherine Monson Cancer Research UK
  More Information

ClinicalTrials.gov Identifier: NCT00082927     History of Changes
Other Study ID Numbers: CRUK-NCRI-RT-02-01
CDR0000361728 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20224
RIB
ISRCTN86185157
First Submitted: May 14, 2004
First Posted: May 19, 2004
Last Update Posted: June 26, 2013
Last Verified: June 2009

Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
bone metastases
pain
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs