Can bone cement stop spine fractures after cancer radiation? new trial aims to find out
NCT ID NCT02387905
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether injecting bone cement into the spine can prevent fractures after high-dose radiation treatment for cancer that has spread to the backbone. About 87 patients with solid tumors and spinal metastases will receive either standard radiation alone or radiation plus cement augmentation. The main goal is to see if the cement reduces the rate of vertebral fractures at 3 months, and also whether it lessens pain and improves quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bone cement (polymethylmethacrylate) injected into the vertebra
- What this could lead to
- If it works, this procedure could become a standard way to prevent painful spine fractures in cancer patients undergoing radiation, reducing the need for further surgery.
- What could go wrong
- This is a small Phase 2 trial with only 87 participants, so results may not apply to everyone. The procedure itself carries risks like cement leakage or infection, and it is not yet proven to prevent fractures long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
87 people
The number who actually took part.
- Started
-
Mar 2015
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
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