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Cement Augmentation for Cancer with Spinal Metastases

Phase 2
Waitlist Available
Led By Amol J Ghia
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
All patients must have a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gray (Gy)
Must not have
Patients who have had prior surgery at the spine level to be treated to include prior cement augmentation, laminectomy, vertebrectomy, tumor debulking, instrumentation
Patients who have frank mechanical pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether using body cement can help prevent a compression fracture after spine stereotactic radiosurgery.

Who is the study for?
This trial is for adults with solid tumors that have spread to the spine, can lie flat, and are at high risk of spinal fractures post-radiosurgery. They should be relatively active (able to care for themselves), expected to live more than 3 months, and agree to use contraception. Those who've had prior spine surgery or radiotherapy at the same spot, severe vertebral damage, or certain cancers like lymphoma aren't eligible.
What is being tested?
The study tests if injecting cement into vertebrae after high-dose radiation therapy (spine stereotactic radiosurgery) prevents fractures in patients with cancerous spine tumors. It's a phase II trial comparing patients receiving cement augmentation against those who don't, assessing pain relief and life quality.
What are the potential side effects?
Potential side effects may include discomfort at the injection site, infection risks from the procedure, possible nerve damage leading to numbness or weakness, allergic reactions to materials used in body cement, and general anesthesia-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a confirmed solid tumor cancer that has spread to my spine.
Select...
I have received a specific radiation dose to my spine.
Select...
I can take care of myself but might not be able to do heavy physical work.
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I have had treatment on up to 3 connected or separate parts of my spine.
Select...
I can lie flat on my back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery on my spine before, such as for tumor removal or bone support.
Select...
I experience clear, mechanical pain.
Select...
My spine condition involves significant disease affecting both sides at a specific level.
Select...
More than half of one of my vertebrae has collapsed.
Select...
I have previously received radiation therapy at the same spine area.
Select...
My cancer is only in the spine's posterior parts.
Select...
I have spinal cord compression.
Select...
I am not eligible for cement augmentation treatment.
Select...
My cancer is either lymphoma, myeloma, or small cell lung cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Vertebral compression fracture rate
Secondary study objectives
Incidence of post-treatment adverse events
Local control
Overall survival
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (vertebral body cement augmentation)Experimental Treatment4 Interventions
Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
Group II: Arm I (standard of care)Active Control3 Interventions
Patients undergo stereotactic spinal radiosurgery per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2021
Completed Phase 2
~440
Management of Therapy Complications
2012
Completed Phase 2
~450

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,158 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,914 Total Patients Enrolled
Amol J GhiaPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Stereotactic Radiosurgery Clinical Trial Eligibility Overview. Trial Name: NCT02387905 — Phase 2
Cancer Research Study Groups: Arm I (standard of care), Arm II (vertebral body cement augmentation)
Cancer Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT02387905 — Phase 2
Stereotactic Radiosurgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT02387905 — Phase 2
~15 spots leftby Dec 2026
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