Houston, Texas 77030


Purpose:

The goal of this clinical research study is to learn whether using body cement on the largest part of the vertebra (a procedure called vertebral body cement augmentation) can help to prevent a fracture following stereotactic spinal radiosurgery. Researchers also want to learn if the procedure can lessen pain and improve quality of life in patients receiving this surgery.


Study summary:

Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. - If you are in Group 1, you will receive stereotactic spinal radiosurgery alone (the standard of care treatment). - If you are in Group 2, you will receive vertebral body cement augmentation within 4 weeks before or after your stereotactic spinal radiosurgery. You will have an equal chance of being in either group. Stereotactic Spinal Radiosurgery: Both groups will receive standard of care stereotactic spinal radiosurgery. You will sign a separate consent for this that will explain the procedure and the risks. Study Procedure: If you are in Group 2, your vertebral body cement augmentation will be performed by a specialist. You will receive a local anesthetic and mild sedation. A small cut is made in your back and, guided by x-ray images, the specialist will inject body cement into the largest part of the vertebra to strengthen it. The specialist may also expand the vertebra if it is at all collapsed. You will lie flat for several hours. You will most likely be discharged on the same day of the procedure, but you may need to stay overnight in the hospital. Follow-Up Visits: No matter which group you are in, you will return to the clinic for follow-up visits every 3 months for 2 years. At these visits, the following tests and procedures will be performed: - You will have a physical exam. - You will a magnetic resonance imaging (MRI) to check the status of your spine. - You will complete 3 questionnaires about your quality of life and any pain you may be having. The questionnaires should take a total of about 10 minutes to complete. Length of Study Participation: Your participation in this study will be over after your follow-up visit at 2 years. This is an investigational study. Body cement is FDA approved for the treatment of vertebral body fractures. It is investigational to study if body cement may prevent vertebral body fractures. Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.


Criteria:

Inclusion Criteria: 1. All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis 2. Age >/= 18 years 3. ECOG performance status </=2 (Karnofsky >/=60%) 4. Life expectancy of greater than 3 months 5. All patients must be able to lie supine 6. 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 7. All patients must have a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gy 8. All patients must be deemed at "high risk" of developing vertebral body fracture by having at least one of the following characteristics: 1) Spine Instability Neoplastic Score classification of "Indeterminate" deemed as a score from 7 to 12; 2) Pre-existing vertebral body fracture; 3) Planned radiation dose of 24 Gy 9. All patients must have a vertebral body site to be treated located from T1 to L5. 10. 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 11. 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 IRB. 12. Patients undergoing bisphosphonate therapy are allowed. Exclusion Criteria: 1. Patients who have had prior radiotherapy at the spine site and level to be treated 2. Patients who have had prior surgery at the spine level to be treated to include prior cement augmentation, laminectomy, vertebrectomy, tumor debulking, instrumentation 3. Patients with gross disease involving only the posterior elements 4. Patients who have >50% vertebral body collapse 5. Patients unable to undergo magnetic resonance imaging (MRI) of the spine 6. Patents with cord compression 7. Patients deemed not be a candidate for cement augmentation for any reason 8. Patients who have frank mechanical pain 9. Patients with both pedicles involved with gross disease at the level of potential cement augmentation 10. Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. 11. Patients with a histology of lymphoma, myeloma and small cell lung cancer histologies


NCT ID:

NCT02387905


Primary Contact:

Principal Investigator
Amol J. Ghia, MD
M.D. Anderson Cancer Center

Amol J. Ghia, MD
Phone: 713-563-2300


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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