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

NCT02387905 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2014-0561NCI-2015-00494
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Malignant Neoplasm in the Spine; Metastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  At 3 months

Secondary Outcomes (8)

• Time to first new or progressive vertebral body fracture

  Up to 2 years

• Pain control, assessed using the Brief Pain Inventory form

  Up to 2 years

• Quality of life, assessed using the MD Anderson Symptom Inventory-Spine Tumor form

  Up to 2 years

• Local control

  Up to 2 years

• Overall survival

  Up to 2 years

Study Arms (2)

Arm I (standard of care)

ACTIVE COMPARATOR

Patients undergo stereotactic spinal radiosurgery per standard of care.

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.

Procedure: Management of Therapy Complications; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (standard of care); Arm II (vertebral body cement augmentation)

Questionnaire Administration OTHER

Ancillary studies

Arm I (standard of care); Arm II (vertebral body cement augmentation)

Stereotactic Radiosurgery RADIATION

Undergo standard stereotactic spinal radiosurgery

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Arm I (standard of care); Arm II (vertebral body cement augmentation)

Management of Therapy Complications PROCEDURE

Undergo vertebral body cement augmentation

Arm II (vertebral body cement augmentation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Amol J Ghia

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 13, 2015
• Study Start: March 9, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)