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

Running, not enrolling · Phase 2

Conditions studied: Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID: NCT02387905
Run by: M.D. Anderson Cancer Center
People needed: 87
Starts: 2015-03-09
Expected to finish: 2026-12-31
Last updated by the study team: 2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Life expectancy of greater than 3 months
All patients must be able to lie supine
All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated
All patients must have a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gray (Gy)
All patients must be deemed at "high risk" of developing vertebral body fracture by having at least one of the following characteristics:
Spine Instability Neoplastic Score classification of "Indeterminate" deemed as a score from 7 to 12
Pre-existing vertebral body fracture
Planned radiation dose of 24 Gy
All patients must have a vertebral body site to be treated located from T1 to L5
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of M.D. Anderson Cancer Center; the only acceptable consent is the one approved by M.D. Anderson Institutional Review Board (IRB)
Patients undergoing bisphosphonate therapy are allowed

You may not qualify if…

Patients who have had prior radiotherapy at the spine site and level to be treated
Patients who have had prior surgery at the spine level to be treated to include prior cement augmentation, laminectomy, vertebrectomy, tumor debulking, instrumentation
Patients with gross disease involving only the posterior elements
Patients who have > 50% vertebral body collapse
Patients unable to undergo magnetic resonance imaging (MRI) of the spine
Patents with cord compression
Patients deemed not be a candidate for cement augmentation for any reason
Patients who have frank mechanical pain
Patients with both pedicles involved with gross disease at the level of potential cement augmentation
Pregnant women are excluded from this study
Patients with a histology of lymphoma, myeloma and small cell lung cancer histologies

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.