Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT02387905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-09
First Post:
2015-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Prophylactic Cement Augmentation for Patients at High Risk for Developing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery: A Randomized Phase II Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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:
This randomized phase II trial studies how well cement augmentation works in preventing vertebral body compression fracture following spine stereotactic radiosurgery in patients with solid tumors that have spread to the spine. Spine stereotactic radiosurgery delivers a high dose of radiation to vertebral metastases and can sometimes lead to a vertebral compression fracture. Using body cement on the largest part of the vertebra (a procedure called vertebral body cement augmentation) may help prevent a fracture after stereotactic spinal radiosurgery. It may also lessen pain and improve quality of life in patients with solid tumors and spinal metastases undergoing this surgery.
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess whether prophylactic cement augmentation reduces new or progressive vertebral body fracture at 3 months in high risk patients undergoing single fraction spine stereotactic radiosurgery.
SECONDARY OBJECTIVES:
I. To assess the impact of prophylactic cement augmentation on time to first new or progressive vertebral body fracture.
II. To assess the impact of prophylactic cement augmentation on pain control measured every three months post treatment.
III. To assess the impact of prophylactic cement augmentation on quality of life measured every three months post treatment.
IV. To estimate local control in each arm. V. To estimate overall survival in each arm. VI. To document and assess post-treatment adverse side effects between the two arms.
VI. To document and assess the relationship between radiographic vertebral body fracture, pain control and quality of life.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo stereotactic spinal radiosurgery per standard of care.
ARM II: Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
After completion of study treatment, patients are followed up every 3 months for 2 years.
I. To assess whether prophylactic cement augmentation reduces new or progressive vertebral body fracture at 3 months in high risk patients undergoing single fraction spine stereotactic radiosurgery.
SECONDARY OBJECTIVES:
I. To assess the impact of prophylactic cement augmentation on time to first new or progressive vertebral body fracture.
II. To assess the impact of prophylactic cement augmentation on pain control measured every three months post treatment.
III. To assess the impact of prophylactic cement augmentation on quality of life measured every three months post treatment.
IV. To estimate local control in each arm. V. To estimate overall survival in each arm. VI. To document and assess post-treatment adverse side effects between the two arms.
VI. To document and assess the relationship between radiographic vertebral body fracture, pain control and quality of life.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo stereotactic spinal radiosurgery per standard of care.
ARM II: Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: