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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT00853528
Eligibility Criteria:
Inclusion Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic spinal tumor
* Localized spinal metastasis, defined as one of the following:
* Solitary spinal metastasis
* Two contiguous spinal levels
* No more than 2 adjacent spinal levels involved by a single tumor
* Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)
* Tumor size ≤ 5 cm
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Life expectancy ≥ 6 months
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be ambulatory
Exclusion Criteria:
* Not pregnant or nursing
* No spinal instability
* No rapid neurological decline
* No bony retropulsions causing neurological abnormalities
* No total paraplegia for \> 48 hours
* No psychological issues that would preclude completion of study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields
* No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance
* No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00853528
Study Brief:
Protocol Section:
NCT00853528