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

NCT ID: NCT02387905

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-09
• Study Completion Date: 2026-12-31

Brief 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. 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:

I. 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:

I. 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.

Conditions

Metastatic Malignant Neoplasm in the Spine; Metastatic Malignant Solid Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (standard of care)

Patients undergo stereotactic spinal radiosurgery per standard of care.

Group Type: ACTIVE_COMPARATOR

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Stereotactic Radiosurgery

Intervention Type: RADIATION

Undergo standard stereotactic spinal radiosurgery

Arm II (vertebral body cement augmentation)

Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.

Group Type: EXPERIMENTAL

Management of Therapy Complications

Intervention Type: PROCEDURE

Undergo vertebral body cement augmentation

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Stereotactic Radiosurgery

Intervention Type: RADIATION

Undergo standard stereotactic spinal radiosurgery

Interventions

Management of Therapy Complications

Undergo vertebral body cement augmentation

Intervention Type: PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Stereotactic Radiosurgery

Undergo standard stereotactic spinal radiosurgery

Intervention Type: RADIATION

Other Intervention Names

Quality of Life Assessment; Stereotactic External Beam Irradiation; stereotactic external-beam radiation therapy; stereotactic radiation therapy; Stereotactic Radiotherapy; stereotaxic radiation therapy; stereotaxic radiosurgery

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amol J Ghia

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2015-00494

Identifier Type: REGISTRY

Identifier Source: secondary_id

2014-0561

Identifier Type: OTHER

Identifier Source: secondary_id

2014-0561

Identifier Type: -

Identifier Source: org_study_id