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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT02527304
Eligibility Criteria:
Inclusion Criteria:
* Localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels with documented epidural cord compression by a screening imaging study (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] myelogram); site may have a maximal involvement of 2 contiguous vertebral bodies; patients with other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible
* History/physical examination by the treating physician within 24 hours prior to registration
* Neurological and functional examination within 24 hours prior to registration by the treating physician
* Negative serum pregnancy test
* MRI (contrast is not required but strongly recommended) or CT myelogram of the involved spine within 1 week prior to registration to determine the extent of the spine involvement
* Numerical rating pain scale within 1 week prior to registration; documentation of the patient's initial pain score is required; patients taking medication for pain at the time of registration are eligible
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry or within 1 week of first treatment, provided other criteria were met
* Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
Exclusion Criteria:
* Histologies of myeloma or lymphoma
* Cord compression at 2 non-contiguous sites in the spine
* Favorable candidates for surgical decompression by prior documented criteria
* Spine instability as determined by Spinal Instability Neoplastic Score (SINS) score \> 12
* \> 50% loss of vertebral body height
* Bony retropulsion causing neurologic abnormality
* Prior radiation to the index spine
* Patients who cannot obtain a contrast-enhanced MRI or CT myelogram due to allergy, renal failure or other medical contraindication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02527304
Study Brief:
Protocol Section:
NCT02527304