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:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT04802603
Eligibility Criteria:
Inclusion Criteria:
* Zubrod Performance Status 0-2
* Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)
* Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
* Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
* For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
* Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)
Exclusion Criteria:
* Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
* Non-ambulatory patients
* \>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
* Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
* Rapid neurologic decline
* Patients for whom an MRI of the spine is medically contraindicated
* Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04802603
Study Brief:
Protocol Section:
NCT04802603