Overview

This trial is active, not recruiting.

Conditions neoplasm, arteriovenous malformations
Treatment radiosurgery
Phase phase 1/phase 2
Sponsor University of Alabama at Birmingham
Collaborator Health Services Foundation
Start date April 2005
End date September 2016
Trial size 36 participants
Trial identifier NCT00573872, F050103003, T0408240012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
To determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery
time frame: 2 years

Secondary Outcomes

Measure
To estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with Tomotherapy
time frame: 2 years
To assess the acute and late toxicity of spinal radiosurgery
time frame: 2 years

Eligibility Criteria

Male or female participants at least 19 years old.

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.

Additional Information

Official title A Phase II Study of Spinal Radiosurgery
Principal investigator John B. Fiveash, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.