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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT00802659
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma)
* Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT
* Have had prior radiation to area of spine felt to be cause of patient's pain
* Zubrod performance status of 0-3
* Life expectancy of ≥ 3 months
* Signed informed consent prior to registration to study
* Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging.
Exclusion Criteria:
* Women who are pregnant or nursing
* Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled'
* No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention)
* No initiation of chemotherapy within 15 days of trial entry.
* No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery.
* No active systemic infection.
* No evidence of myelopathy or cauda equina syndrome on clinical evaluation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00802659
Study Brief:
Protocol Section:
NCT00802659