Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082927
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2004-05-14
Brief Title:
Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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 8Gy1f
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
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 8Gy1f
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN86185157 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000361728 | REGISTRY | None | None |
| EU-20224 | None | None | None |
| RIB | None | None | None |