N/A
N=43
A Phase II Study of Spinal Radiosurgery
Neoplasm · Arteriovenous Malformations
Bottom Line
View on ClinicalTrials.gov: NCT00573872 ↗Enrolled (actual)
43
Serious AEs
3.1%
Results posted
Oct 2017
Primary outcome: Primary: Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy — 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiosurgery (Radiation)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy |
29 | — |
| PRIMARY Assess the Acute and Late Toxicity of Spinal Radiosurgery |
4 | — |
| PRIMARY Number of Participants With Lack of Tumor Growth at Last Follow-up |
21 | — |
Summary
Phase I of the study (motion and quality assurance [QA] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.
Eligibility Criteria
Inclusion Criteria
- All subjects must have history of histologically confirmed neoplasm or radiographically-diagnosed AVM. Patients without a prior tissue diagnosis but who have a radiographically characteristic lesion are eligible if there is consensus agreement of the diagnosis in the UAB Neuro-oncology Tumor Board.
- ECOG performance status of less than or equal to 2
- Age greater than 18
- Life expectancy greater than 12 weeks
- Subjects given written informed consent
Exclusion Criteria
- Cytotoxic chemotherapy within 7 days of treatment
- Insufficient recovery from all active toxicities of prior therapies
- Epidural spinal cord compression requiring immediate neurosurgical decompression. If a patient requires immediate surgery for neurologic compromise, they may still be eligible post operatively if tumor was incompletely resected.
- Patient is non-ambulatory. Optimization of pretreatment neurologic function with steroids is allowed. Ambulation with assistance of walker or cane is allowed.
- Patient is pregnant and it is judged by the treating Radiation Oncologist that spinal radiosurgery would place the fetus in unacceptable danger.
Data sourced from ClinicalTrials.gov (NCT00573872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.