Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365105
Status:
COMPLETED
Last Update Posted:
2019-06-14
First Post:
2006-08-16
Brief Title:
Zoledronate Vitamin D and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer Lung Cancer or Breast Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung Breast and Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2024-09
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 Zoledronate vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer lung cancer or breast cancer
PURPOSE This randomized phase III trial is studying zoledronate vitamin D and calcium to see how well they work compared to zoledronate vitamin D calcium and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer lung cancer or breast cancer
PURPOSE This randomized phase III trial is studying zoledronate vitamin D and calcium to see how well they work compared to zoledronate vitamin D calcium and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer lung cancer or breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of zoledronate vitamin D and calcium with or without strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium in terms of preventing or delaying the time to development of malignant skeletal-related events SREs defined as a pathological bone fracture spinal cord compression surgery to bone or radiation to bone in patients with bone metastases secondary to prostate lung or breast cancer
Secondary
Compare the rate of SREs at 1 year in patients treated with these regimens
Compare overall survival of patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare the effect of these regimens on pain control in these patients
Evaluate resource utilization and cost effectiveness of these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to primary disease site prostate vs breast vs lung and number of bone metastases 2 vs 2 Patients are randomized to 1 of 2 treatment arms
Quality of life and pain are assessed at baseline and then at 1 3 6 and 12 months from start of protocol treatment
After completion of study treatment patients are followed every 6 months
Primary
Compare the efficacy of zoledronate vitamin D and calcium with or without strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium in terms of preventing or delaying the time to development of malignant skeletal-related events SREs defined as a pathological bone fracture spinal cord compression surgery to bone or radiation to bone in patients with bone metastases secondary to prostate lung or breast cancer
Secondary
Compare the rate of SREs at 1 year in patients treated with these regimens
Compare overall survival of patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare the effect of these regimens on pain control in these patients
Evaluate resource utilization and cost effectiveness of these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to primary disease site prostate vs breast vs lung and number of bone metastases 2 vs 2 Patients are randomized to 1 of 2 treatment arms
Quality of life and pain are assessed at baseline and then at 1 3 6 and 12 months from start of protocol treatment
After completion of study treatment patients are followed every 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-00727 | REGISTRY | CTRP Clinical Trial Reporting Program | None |
| CDR0000491233 | None | None | None |