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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02167633
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histological or cytological confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
* Patients must have localized spine metastasis from first cervical to last lumbar vertebra with evidence of radiological SCC (rSCC) on a diagnostic MRI defined as involvement or compression of either the spinal cord or the cauda equina by an epidural mass lesion or metastatic disease causing impingement, indentation or loss of definition of the thecal sac
* A maximum of two separate sites requiring treatment is allowed with maximum two vertebra pr. site
* Eligible for surgery defined by technical assessment by surgeon whether surgical decompression is possible with proper stabilization of the spine
* No medical co-morbidity contradicting anesthesia
* Patient without former treatment for metastatic spinal cord compression with either decompressive surgery and/or radiation therapy
* Patient with mild to moderate neurologic signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 on MRC scale
* Age ≥18 years
* ECOG performance status ≤2
* Life expectancy of greater than 3 months
* The effects of ionizing radiation on the developing human fetus are known to be teratogenic. For this reason women of child-bearing potential and men must agree to use adequate contraception 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of radiation therapy administration
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Histology of myeloma or lymphoma
* Patients with any spine metastasis that is not planned to be treated per protocol
* Spine instability due to a compression fracture or impending vertebral compression fracture
* Patients with rapid neurologic decline within 24 hours
* Bony retropulsion causing neurologic abnormality
* Prior radiation to the index spine
* Patients for whom an MRI of the spine is medically contraindicated
* Patients allergic to contrast dye used in MRIs
* Patients who are receiving any other investigational agents
* Patients with more than two known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
* Patient with any serious neurologic condition other than MSCC that could confound the diagnosis and interpretation of radiation induced myelopathy
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02167633
Study Brief:
Protocol Section:
NCT02167633