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ACTIVE NOT RECRUITING
NCT02387905
PHASE2

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

87

Start Date

2015-03-09

Completion Date

2026-12-31

Last Updated

2025-10-09

Healthy Volunteers

No

Interventions

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States