A Study of Spinal Radiosurgery (RAD0408)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Health Services Foundation
The Kirklin Clinic at Acton Road
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00573872
First received: December 12, 2007
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Neoplasm
Arteriovenous Malformations
Radiation: Radiosurgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Spinal Radiosurgery

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • To determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To assess the acute and late toxicity of spinal radiosurgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Radiosurgery

    Phase I: 20-25 Gy in 5 fractions

    Phase II: 9-24 GY in 1 fraction

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
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573872

Locations
United States, Alabama
University of Alabama at Birmingham/The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Health Services Foundation
The Kirklin Clinic at Acton Road
Investigators
Principal Investigator: John B. Fiveash, M.D. University of Alabama at Birmingham
  More Information

Publications:
Abbatucci JS, Delozier T, Quint R, et al: Radiation myelopathy of the cervical spinal cord: time, dose and volume factors. Int J Radiat Oncol Biol Phys 4:239-248, 1978
Ang KK, Jiang GL, Feng Y, et al: Extent and kinetics of recovery of occult spinal cord injury. Int J Radiat Oncol Biol Phys 50:1013-1020, 2001
Nieder C: Recommendation of Human Spinal Cord Re-irradiation Dose Based on Data From 39 Patients. Int J Radiat Oncol Biol Phys 57:373, 2003
Schultheiss TE, Stephens LC, Jiang GL, et al: Radiation myelopathy in primates treated with conventional fractionation. Int J Radiat Oncol Biol Phys 19:935-940, 1990
Schultheiss TE, Stephens LC, Maor MH: Analysis of the histopathology of radiation myelopathy. Int J Radiat Oncol Biol Phys 14:27-32, 1988

Responsible Party: John Fiveash, MD, Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00573872     History of Changes
Other Study ID Numbers: F050103003, T0408240012
Study First Received: December 12, 2007
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Radiosurgery
Phase II
Cancer
Spinal
AVM

Additional relevant MeSH terms:
Arteriovenous Malformations
Congenital Abnormalities
Hemangioma
Cardiovascular Abnormalities
Cardiovascular Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Vascular Diseases
Vascular Malformations

ClinicalTrials.gov processed this record on October 29, 2014