Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
|
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. |
| ClinicalTrials.gov Identifier: NCT00082927 |
|
Recruitment Status :
Completed
First Posted : May 19, 2004
Last Update Posted : June 26, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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.
| 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 |
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, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| OverallOfficial: | Heather Purnell | Cancer Research UK | |
| OverallOfficial: | Katherine Monson | Cancer Research UK |
| ClinicalTrials.gov Identifier: | NCT00082927 |
| Other Study ID Numbers: |
CRUK-NCRI-RT-02-01 CDR0000361728 ( Registry Identifier: PDQ (Physician Data Query) ) EU-20224 RIB ISRCTN86185157 |
| First Posted: | May 19, 2004 Key Record Dates |
| Last Update Posted: | June 26, 2013 |
| Last Verified: | June 2009 |
|
stage IV prostate cancer bone metastases pain recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Prostatic Diseases Ibandronic Acid Bone Density Conservation Agents Physiological Effects of Drugs |