Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267033
Status:
COMPLETED
Last Update Posted:
2008-12-02
First Post:
2005-12-19
Brief Title:
Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases EVAR
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases
Status:
COMPLETED
Status Verified Date:
2007-03
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:
A randomized phase III study of palliative external beam radiotherapy RTOG 97-14 has shown that 8 Gy in a single fraction is very effective in providing pain relief with complete or partial improvement in pain seen in 66 of patients with bone metastases Percutaneous vertebroplasty PV is a technique designed to consolidate pathologic vertebral bodies through the injection of orthopaedic cement under fluoroscopic guidance Consolidation provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis haemangiomas myeloma and metastatic diseases with complete or partial improvement in pain seen in 70-85 of patients To date no randomized trial has tested the association of vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous spine metastases
A randomized trial has been designed to determine whether vertebroplasty and radiotherapy 8 Gy in a single fraction provide enhancement pain and narcotic relief compared to radiotherapy alone for patients with painful osseous spine metastases
A randomized trial has been designed to determine whether vertebroplasty and radiotherapy 8 Gy in a single fraction provide enhancement pain and narcotic relief compared to radiotherapy alone for patients with painful osseous spine metastases
Detailed Description:
Patients with 1 to 4 painful osseous spine metastases are randomized to 1 of 2 treatment arms
Arm 1 8 Gy in a single fraction
Arm 2 8 Gy in a single fraction followed by vertebroplasty of the vertebral bodies within 14 days after radiotherapy
Arm 1 8 Gy in a single fraction
Arm 2 8 Gy in a single fraction followed by vertebroplasty of the vertebral bodies within 14 days after radiotherapy
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 |
|---|---|---|---|
| AOM04013 | None | None | None |