NCT02387905

Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Malignant Neoplasm in the Spine
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Management of Therapy Complications	Undergo vertebral body cement augmentation
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Radiosurgery	Undergo standard stereotactic spinal radiosurgery

Timeline

• Start date: 2015-03-09
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2015-03-13
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study