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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a confirmed solid tumor cancer that has spread to my spine.
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I have received a specific radiation dose to my spine.
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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.
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I can lie flat on my back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vertebral compression fracture rate
Secondary outcome measures
Incidence of post-treatment adverse events
Local control
Overall survival
+5 moreTrial 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
2016
Completed Phase 2
~460
Management of Therapy Complications
2012
Completed Phase 2
~450
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,694 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,066 Total Patients Enrolled
1 Trials studying Metastasis
2 Patients Enrolled for Metastasis
Amol J GhiaPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my spine before, such as for tumor removal or bone support.I have a confirmed solid tumor cancer that has spread to my spine.I experience clear, mechanical pain.I have received a specific radiation dose to my spine.My spine condition involves significant disease affecting both sides at a specific level.I can take care of myself but might not be able to do heavy physical work.I have had treatment on up to 3 connected or separate parts of my spine.More than half of one of my vertebrae has collapsed.I have previously received radiation therapy at the same spine area.My cancer is only in the spine's posterior parts.I have spinal cord compression.I can lie flat on my back.I am not eligible for cement augmentation treatment.My cancer is either lymphoma, myeloma, or small cell lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (standard of care)
- Group 2: Arm II (vertebral body cement augmentation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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