Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT02387905
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02387905
Study Brief:
Protocol Section:
NCT02387905