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 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT01254903
Eligibility Criteria:
Inclusion Criteria:
1. Greater than or equal to 18 years old
2. Radiographically documented metastatic epidural compression on spine Magnetic resonance imaging (MRI) within 4 weeks of registration, defined radiographically, ranging from minimal canal compromise and thecal indentation to actual displacement of the spinal cord.
3. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
4. Signed Informed consent
5. Diagnosis of cancer (not one of the more radiosensitive histologies, see exclusion criteria) including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors
6. Motor Strength \>/= 4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
7. Karnofsky performance status (KPS) \>/= 40
8. Patients deemed to be inoperable by patient refusal, by neurosurgical evaluation, or for any reason
Exclusion Criteria:
1. Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors) as conventional radiation is likely to be effective
2. Prior irradiation of the spine site and level to be treated
3. Inability to tolerate lying flat on treatment table for greater than 30 minutes.
4. Patients unable to undergo MRI of the spine
5. Patients who are pregnant
6. Patients who have cord compression from bone components or configuration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01254903
Study Brief:
Protocol Section:
NCT01254903