Arteriovenous Malformations, Neoplasm
Conditions
Keywords
Radiosurgery, Phase II, Cancer, Spinal, AVM
Brief 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.
Detailed description
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: * greater than six months since completion of RT * at least 20 Gy, but no more than 50 Gy
Interventions
RADIATIONRadiosurgery
Phase I: 20-25 Gy in 5 fractions Phase II: 9-24 GY in 1 fraction
Sponsors
Health Services Foundation
The Kirklin Clinic at Acton Road
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. ECOG performance status of less than or equal to 2 3. Age greater than 18 4. Life expectancy greater than 12 weeks 5. Subjects given written informed consent
Exclusion criteria
1. Cytotoxic chemotherapy within 7 days of treatment 2. Insufficient recovery from all active toxicities of prior therapies 3. 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. 4. Patient is non-ambulatory. Optimization of pretreatment neurologic function with steroids is allowed. Ambulation with assistance of walker or cane is allowed. 5. Patient is pregnant and it is judged by the treating Radiation Oncologist that spinal radiosurgery would place the fetus in unacceptable danger.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy | 2 years | 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. |
| Assess the Acute and Late Toxicity of Spinal Radiosurgery | 2 years | 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. |
| Number of Participants With Lack of Tumor Growth at Last Follow-up | 2 years | Lack of tumor growth by CT or MRI at last follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Radiosurgery 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.
Radiosurgery: Phase I: 20-25 Gy in 5 fractions
Phase II: 9-24 GY in 1 fraction | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Spinal Radiosurgery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 32 |
| serious Total, serious adverse events | 1 / 32 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Radiosurgery | Assess the Acute and Late Toxicity of Spinal Radiosurgery | 4 events |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spinal Radiosurgery | Number of Participants With Lack of Tumor Growth at Last Follow-up | 21 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spinal Radiosurgery | Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy | 29 Participants |