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A Phase II Study of Spinal Radiosurgery


Phase 1/Phase 2
19 Years
N/A
Open (Enrolling)
Both
Neoplasm, Arteriovenous Malformations

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Trial Information

A Phase II Study 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:

- greater than six months since completion of RT

- at least 20 Gy, but no more than 50 Gy


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

John B. Fiveash, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Institutional Review Board

Study ID:

F050103003

NCT ID:

NCT00573872

Start Date:

April 2005

Completion Date:

December 2013

Related Keywords:

  • Neoplasm
  • Arteriovenous Malformations
  • Radiosurgery
  • Phase II
  • Cancer
  • Spinal
  • AVM
  • Congenital Abnormalities
  • Arteriovenous Malformations
  • Aneurysm
  • Hemangioma
  • Neoplasms

Name

Location
University of Alabama at Birmingham/The Kirklin Clinic at Acton Road Birmingham, Alabama  35233