Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003162
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Randomized Trial of Palliative Radiation Therapy for Osseous Metastases A Study of Palliation of Symptoms and Quality of Life
Status:
COMPLETED
Status Verified Date:
2015-11
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 Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known which radiation therapy regimen is more effective for bone metastases
PURPOSE Randomized phase III trial to compare different radiation therapy regimens in treating patients who have bone metastases from breast or prostate cancer
PURPOSE Randomized phase III trial to compare different radiation therapy regimens in treating patients who have bone metastases from breast or prostate cancer
Detailed Description:
OBJECTIVES
Compare the ability of a single fraction of radiation therapy vs multiple fractions to provide complete pain relief in patients with painful bone metastases from breast or prostate cancer
Determine the frequency and duration of pain relief and narcotic relief after these treatments in these patient populations
Compare the effect on quality of life of these two treatments in these patient populations
Compare the incidence of pathologic fracture within the treatment fields after these two treatments in these patient populations
OUTLINE This is a randomized study
Patients are assigned to 1 of 2 treatment arms Arm I consists of radiation therapy delivered in 10 fractions over 2 weeks Arm II consists of a single dose of radiation therapy Any retreatment does not occur until at least 4 weeks after prior treatment unless there is an increase of 2 points on the pain score
Patients are followed and quality of life is assessed at 2 and 4 weeks then at 2 3 6 9 and 12 months every 6 months for the next 3 years then annually until death
PROJECTED ACCRUAL This study will accrue 938 patients within 2 years
Compare the ability of a single fraction of radiation therapy vs multiple fractions to provide complete pain relief in patients with painful bone metastases from breast or prostate cancer
Determine the frequency and duration of pain relief and narcotic relief after these treatments in these patient populations
Compare the effect on quality of life of these two treatments in these patient populations
Compare the incidence of pathologic fracture within the treatment fields after these two treatments in these patient populations
OUTLINE This is a randomized study
Patients are assigned to 1 of 2 treatment arms Arm I consists of radiation therapy delivered in 10 fractions over 2 weeks Arm II consists of a single dose of radiation therapy Any retreatment does not occur until at least 4 weeks after prior treatment unless there is an increase of 2 points on the pain score
Patients are followed and quality of life is assessed at 2 and 4 weeks then at 2 3 6 9 and 12 months every 6 months for the next 3 years then annually until death
PROJECTED ACCRUAL This study will accrue 938 patients within 2 years
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-P97-0124 | None | None | None |
| CDR0000065957 | None | None | None |
| NCCTG-R9714 | None | None | None |