An interventional study of Radiosurgery in Neoplasm and Arteriovenous Malformations, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-12-05.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
Optimal radiation plan is generated that treats the tumor (CTV) and spares normal tissue, especially the spinal cord. Motion and QA study will determine intrafraction motion for phase II portion of the study.
Dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area:
Phase I - Motion and QA Study: 20-25 Gy in 5 fractions/10-20 patients/previous RT = \<50% CTV dose/No previous RT = \<80% CTV dose.
Phase II - 9-24 Gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior RT and 15 without prior RT/previous RT = 8 Gy/No previous RT = 10 Gy.
# Motion and QA study will treat CTV to 20-25 Gy in 5 fractions to study intrafraction motion for QA of single fraction administration. This will define treatment margins for single fraction radiosurgery.
*Previous RT:
120 studies on the registry are indexed under Arteriovenous Malformations; 32 are open to participants now.
This study's enrollment of 43 is below the median of 59 across 59 interventional studies indexed under Arteriovenous Malformations.
Browse Arteriovenous Malformations studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.
Radiation: Radiosurgery
Phase I: 20-25 Gy in 5 fractions Phase II: 9-24 GY in 1 fraction
Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy
Physician's subjective report of palliative pain relief. The maximal benefit patient received (best response) is reported. Scale is pain described as "worse", "stable", "better", or "completely resolved". In the reporting "better" or "completely resolved" indicates response to treatment.
Time frame: 2 years
Assess the Acute and Late Toxicity of Spinal Radiosurgery
CTCAE version 3. Acute toxicity will be recorded if toxicity occurs early phase or within 3 months, and late toxicity would be any toxicity that follows those 3 months.
Time frame: 2 years
Number of Participants With Lack of Tumor Growth at Last Follow-up
Lack of tumor growth by CT or MRI at last follow-up
Time frame: 2 years
| Milestone | Spinal Radiosurgery |
|---|---|
| Started | 43 |
| Completed | 32 |
| Not completed | 11 |
Physician's subjective report of palliative pain relief. The maximal benefit patient received (best response) is reported. Scale is pain described as "worse", "stable", "better", or "completely resolved". In the reporting "better" or "completely resolved" indicates response to treatment.
| Participants | Spinal Radiosurgery |
|---|---|
| Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy | 29 |
CTCAE version 3. Acute toxicity will be recorded if toxicity occurs early phase or within 3 months, and late toxicity would be any toxicity that follows those 3 months.
| events | Spinal Radiosurgery |
|---|---|
| Assess the Acute and Late Toxicity of Spinal Radiosurgery | 4 |
Lack of tumor growth by CT or MRI at last follow-up
| Participants | Spinal Radiosurgery |
|---|---|
| Number of Participants With Lack of Tumor Growth at Last Follow-up | 21 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spinal Radiosurgery | — | 1/32 (3.1%) | 1/32 (3.1%) |
| Event | Spinal Radiosurgery |
|---|---|
| Hospitalization for PneumoniaRespiratory, thoracic and mediastinal disorders | 1/32 |
| Worsening neurological symptoms from progressive spinal diseaseNervous system disorders | 1/32 |
| Event | Spinal Radiosurgery |
|---|---|
| Grade 2 myelopathyNervous system disorders | 1/32 |
| Age, Categorical(Participants) | Spinal Radiosurgery |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 13 |
| Sex: Female, Male(Participants) | Spinal Radiosurgery |
|---|---|
| Female | 13 |
| Male | 19 |
| Race (NIH/OMB)(Participants) | Spinal Radiosurgery |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 28 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham