Metastatic Malignant Neoplasm in the SpinePhase 2NCT02387905
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
A Phase 2 study testing Management of Therapy Complications, Quality-of-Life Assessment and Questionnaire Administration in people with Metastatic Malignant Neoplasm in the Spine and Metastatic Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Management of Therapy Complications, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2015to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess whether prophylactic cement augmentation reduces new or progressive vertebral body fracture at 3 months in high risk patients undergoing single fraction spine stereotactic radiosurgery.
SECONDARY OBJECTIVES:
- To assess the impact of prophylactic cement augmentation on time to first new or progressive vertebral body fracture.
II. To assess the impact of prophylactic cement augmentation on pain control measured every three months post treatment.
III. To assess the impact of prophylactic cement augmentation on quality of life measured every three months post treatment.
IV. To estimate local control in each arm. V. To estimate overall survival in each arm. VI. To document and assess post-treatment adverse side effects between the two arms.
VI. To document and assess the relationship between radiographic vertebral body fracture, pain control and quality of life.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo stereotactic spinal radiosurgery per standard of care.
ARM II: Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
After completion of study treatment, patients are followed up every 3 months for 2 years.
- Being tested
- Management of Therapy Complications, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Radiosurgery
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of Therapy ComplicationsProcedure or surgery
Undergo vertebral body cement augmentation
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Stereotactic RadiosurgeryRadiation
Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy
Undergo standard stereotactic spinal radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard of care) | Active comparator | Patients undergo stereotactic spinal radiosurgery per standard of care. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery |
| Arm II (vertebral body cement augmentation) | Experimental | Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery. Receives: Procedure: Management of Therapy Complications; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertebral compression fracture rate
Will compare the 3-month vertebral compression fracture proportions between treatment groups using the Fisher exact test. Will be performed on the intention-to-treat principle.
Measured: At 3 months
Secondary outcomes (8)
Time to first new or progressive vertebral body fracture
To assess the impact of prophylactic cement augmentation on time to first new or progressive vertebral body fracture, will use the Kaplan-Meier method to estimate the freedom from fracture curves and Cox proportional hazards regression analysis to estimate the hazard ratio with confidence intervals and associated p-values.
Measured: Up to 2 years
Pain control, assessed using the Brief Pain Inventory form
Will use mixed effects linear models to analyze this longitudinal data.
Measured: Up to 2 years
Quality of life, assessed using the MD Anderson Symptom Inventory-Spine Tumor form
Participants are asked to recall symptom severity and interference during the past 24 hours. Part I, The severity of the symptoms, including pain, fatigue, nausea, disturbed sleep, short of breath etc. Part II, How have the symptoms interfered with patient life, including mood, work, relations with other people etc. Part I, range 0-10. A score of 0 would mean the symptom is not present and a score of 10 means the symptom is as bad as you can imagine). Part II, range 0-10 (A score of 0 would mean the symptom did not interfere; A score of 10 means the symptom has interfered completely. The ratings in the MDASI can be averaged into several subscale scores: mean core symptom severity, mean module symptom severity, mean total symptom severity, and mean interference. The interference items can further be broken down into mean activity interference and mean affective interference. Symptom items may be presented individually
Measured: Up to 2 years
Local control
Will estimate time to first local failure curves using the Kaplan-Meier method.
Measured: Up to 2 years
Overall survival
Will use the Kaplan-Meier method.
Measured: Up to 2 years
Incidence of post-treatment adverse events
Will estimate the difference in grade 3+ toxicity rates, with 95% confidence intervals and a chi-squared test p-value.
Measured: Up to 2 years
Radiographic vertebral body fracture, pain control and quality of life assessment
Will assess the relationship between radiographic vertebral body fracture, pain control and quality of life using correlation analyses. Additional analyses may be conducted as appropriate.
Measured: Up to 2 years
Quality of life, assessed using the EuroQol 5-dimensional 5-level questionnaire.
Will use mixed effects linear models to analyze this longitudinal data. The questionnaire consists 2 parts.
Part 1 is descriptive system (participants are asked mobility, self-care status, usual activities, pain/discomfort, anxiety/depression, and each dimension has 5 levels;
Part 2 is the Visual analogue scale (the self-rated health today with score 0-100; 100 means the best health you can imagine. 0 means the worst health you can imagine) Part 2, participants give self-rated health today with 100 means the best health you can imagine. 0 means the worst health you can imagine. Part 2, higher range represents a better outcome
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study start9 Mar 2015
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Neoplasm in the SpineStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amol J Ghia, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387905
- Sponsor's protocol ID
- 2014-0561
- Other IDs
- NCI-2015-00494, 2014-0561
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2015
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02387905
- Acronym / sponsor ID
- 2014-0561
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To assess whether prophylactic cement augmentation reduces new or progressive vertebral body fracture at 3 months in high risk patients undergoing single fraction spine stereotactic radiosurgery.
SECONDARY OBJECTIVES:
- To assess the impact of prophylactic cement augmentation on time to first new or progressive vertebral body fracture.
II. To assess the impact of prophylactic cement augmentation on pain control measured every three months post treatment.
III. To assess the impact of prophylactic cement augmentation on quality of life measured every three months post treatment.
IV. To estimate local control in each arm. V. To estimate overall survival in each arm. VI. To document and assess post-treatment adverse side effects between the two arms.
VI. To document and assess the relationship between radiographic vertebral body fracture, pain control and quality of life.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo stereotactic spinal radiosurgery per standard of care.
ARM II: Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard of care) | Active comparator | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Stereotactic RadiosurgeryPatients undergo stereotactic spinal radiosurgery per standard of care. |
| Arm II (vertebral body cement augmentation) | Experimental | Procedure: Management of Therapy Complications, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Stereotactic RadiosurgeryPatients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Management of Therapy ComplicationsUndergo vertebral body cement augmentation | Procedure or surgery | Arm II (vertebral body cement augmentation) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (standard of care), Arm II (vertebral body cement augmentation) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (standard of care), Arm II (vertebral body cement augmentation) |
| Stereotactic RadiosurgeryAlso: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic RadiotherapyUndergo standard stereotactic spinal radiosurgery | Radiation | Arm I (standard of care), Arm II (vertebral body cement augmentation) |
Primary outcome
Vertebral compression fracture rate
Time frame: At 3 months
Will compare the 3-month vertebral compression fracture proportions between treatment groups using the Fisher exact test. Will be performed on the intention-to-treat principle.
8 secondary outcomes
Time to first new or progressive vertebral body fracture
Time frame: Up to 2 years
Pain control, assessed using the Brief Pain Inventory form
Time frame: Up to 2 years
Quality of life, assessed using the MD Anderson Symptom Inventory-Spine Tumor form
Time frame: Up to 2 years
Local control
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Incidence of post-treatment adverse events
Time frame: Up to 2 years
Radiographic vertebral body fracture, pain control and quality of life assessment
Time frame: Up to 2 years
Quality of life, assessed using the EuroQol 5-dimensional 5-level questionnaire.
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol J Ghia principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Management of Therapy Complications, Quality-of-Life Assessment and Questionnaire Administration in people with Metastatic Malignant Neoplasm in the Spine and Metastatic Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertebral compression fracture rate (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.